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| Lot Number AW2098, CW9498 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Inflammation (1932); Irritation (1941); Burn, Thermal (2530)
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| Event Date 09/07/2020 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation], , narrative: this is a spontaneous report from a contactable consumer.This (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual, lot number cw9498 and expiry date dec2022, upc number: 305733020029, lot number aw2098 and expiry date apr2022) from (b)(6) 2020 to (b)(6) 2020 at unknown dose for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6) 2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday (07sep2020) was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number aw2098 and expiry date apr2022).She did not know what it means but next to that it says s (b)(6).She says on the bottom left of the individual packaging she sees (b)(6).The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on (b)(6) 2020.Outcome of events was not recovered.Additional information has been requested and will be provided as it becomes available.
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Manufacturer Narrative
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Summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.Summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.
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Event Description
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Event verbatim [preferred term], large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation], narrative: this is a spontaneous report from a contactable consumer.This 28-year-old female patient started to receive thermacare heatwrap (thermacare menstrual, lot number cw9498 and expiry date dec2022, upc/udi number: (b)(4), lot number aw2098 and expiry date apr2022) from (b)(6) 2020 at unknown dose for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6) 2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday ((b)(6) 2020) was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number aw2098 and expiry date apr2022).She did not know what it means but next to that it says s 05/10.She says on the bottom left of the individual packaging she sees (b)(6).The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on (b)(6) 2020.Outcome of events was not recovered.According to the product quality complaint group: summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.Additional investigational results from the product quality complaint included summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Follow-up (15sep2020): follow-up attempts are completed.No further information is expected.Follow-up (14sep2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (16sep2020): new information received from the product quality complaint group includes investigational results.Follow up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.Additional investigational results from the product quality complaint included summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective (b)(6) 2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective (b)(6)2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual (b)(6)2017 to (b)(6)2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective (b)(6)2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.
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Event Description
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Event verbatim [preferred term].Large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation], , narrative: this is a spontaneous report from a contactable consumer.This 28-year-old female patient started to receive thermacare heatwrap (thermacare menstrual, lot number cw9498 and expiry date dec2022, upc/udi number: (b)(4), lot number aw2098 and expiry date apr2022) from (b)(6) 2020 to (b)(6) 2020 at unknown dose for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6)2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday (b)(6) 2020 was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number aw2098 and expiry date apr2022).She did not know what it means but next to that it says s 05/10.She says on the bottom left of the individual packaging she sees paa115871.The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on (b)(6)2020.Outcome of events was not recovered.According to the product quality complaint group: summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.Additional investigational results from the product quality complaint included summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective (b)(6) 2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective(b)(6) 2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual (b)(6)2017 to (b)(6)2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Follow-up (15sep2020): follow-up attempts are completed.No further information is expected.Follow-up (14sep2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (16sep2020): new information received from the product quality complaint group includes investigational results.Follow up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.
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Event Description
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Event verbatim [preferred term].Large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation], , narrative: this is a spontaneous report from a contactable consumer.This 28-year-old female patient started to receive thermacare heatwrap (thermacare menstrual, lot number cw9498 and expiry date dec2022, upc/udi number: (b)(4), lot number aw2098 and expiry date apr2022) from (b)(6) 2020 at unknown dose for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6) 2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday (b)(6) 2020 was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number aw2098 and expiry date apr2022).She did not know what it means but next to that it says s 05/10.She says on the bottom left of the individual packaging she sees (b)(4).The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on (b)(6) 2020.Outcome of events was not recovered.According to the product quality complaint group: summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.Additional investigational results from the product quality complaint included summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective 24feb2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual (b)(6) 2017 to (b)(6) 2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.Follow-up (15sep2020): follow-up attempts are completed.No further information is expected.Follow-up (14sep2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (16sep2020): new information received from the product quality complaint group includes investigational results.Follow up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: evaluation code method - historical data analysis was added.
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Manufacturer Narrative
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Summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.Additional investigational results from the product quality complaint included summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective 24feb2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual (b)(6) 2017 to (b)(6) 2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.
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Manufacturer Narrative
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Summary of investigation: batch: aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.
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Event Description
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Large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation].Narrative: this is a spontaneous report from a contactable consumer.This 28-year-old female patient started to receive thermacare heatwrap (thermacare menstrual, lot number: cw9498 and expiry date: dec2022, upc/udi number: (b)(4), lot number: aw2098 and expiry date: apr2022) from on (b)(6) 2020, at unknown dose for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6) 2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday (on (b)(6) 2020) was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number: aw2098 and expiry date: apr2022).She did not know what it means but next to that it says s 05/10.She says on the bottom left of the individual packaging she sees paa115871.The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on 07sep2020.Outcome of events was not recovered.According to the product quality complaint group: summary of investigation: batch: aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Site sample status was not received.Follow-up (15sep2020): follow-up attempts are completed.No further information is expected.Follow-up (14sep2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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On (b)(6)2020, according to the product quality complaint group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.On (b)(6)2020, additional investigational results from the product quality complaint included : complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.On (b)(6)2020, the product quality complaint group provided updated trend information: complaint sub-class: adverse event/serious/unknown: lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective 24feb2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual 08sep2017 to 08sep2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.On 13nov2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare menstrual.Device lot number: cw9498.Expiration date: dec2022.Complaint sub-class: adverse event/serious/unknown.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: the manufacturing site reported the dhr, reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.Customer reported patient had large red burns from where the product was on her stomach.She has bad burns from where the cells are, she has 8 different burns from each of the 8 cells, there are 2 that are more red and inflamed and more puffed up, she says they feel raised and inflamed for thermacare menstrual heatwraps.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures above the upper specification limit.Root cause/capa: process related?: n/a; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable (complaint not confirmed).Conclusion: based on the complaint narrative, the manufacturing site reported the dhr, reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.Customer reported patient had large red burns from where the product was on her stomach.She has bad burns from where the cells are, she has 8 different burns from each of the 8 cells, there are 2 that are more red and inflamed and more puffed up, she says they feel raised and inflamed for thermacare menstrual heatwraps.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures above the upper specification limit.
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Event Description
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Event verbatim [preferred term] large red burns from where the product was on her stomach [application site burn], inflamed [application site inflammation], , narrative: this is a spontaneous report from a contactable consumer (patient).This 28-year-old female patient started to use thermacare heatwrap (thermacare menstrual, lot number cw9498 and expiry date dec2022, upc/udi number: (b)(4), lot number aw2098 and expiry date apr2022) on (b)(6)2020 for real bad menstrual cramps.Medical history and concomitant medications were not reported.On (b)(6)2020, the patient noticed she had large red burns from where the product was on her stomach.Patient used 3 wraps and she noticed, she just finished her cycle and she noticed she had large red burns from where the product was on her stomach.So it was like at the bottom of her stomach and the top of her woman area.She had bad burns from where the cells were, so on the product there were 8 different pouches that had the iron in them or whatever and she had 8 different burns from each of the 8 cells.She said this was her first time using this product and she had redness shaped like the heat cells.There were 8 cells and she had 8 burns.She said 2 of them were particularly worse than the other 6.She said 2 were more red and inflamed and more puffed up, they feel raised and inflamed.She said they were still ongoing, she had not used it since yesterday ((b)(6)2020) was when she noticed it.She said she didn't know exactly when it occurred.She said there was a few hours between using them.She knew it kind of felt irritated but she didn't notice too much because she had been cramping really bad with her cycle but her boyfriend noticed and then after she showered it was really irritated.She said she may have the 3 separate bags but she may have the box.She didn't finish the last box because they bought 2 boxes of them and she was using the second box, she had taken one out of the second box and used it then she noticed the bumps.She said they were 3 count boxes.She said the first box was trashed last night, so she didn't have the first box anymore but she had the box she had used from when she noticed the burns.She did buy them at different places.She clarified there was a couple hours between uses of each wrap.She used a total of 4 wraps, 3 from one box and then 1 from the second box.She had not required any medical treatment for this at this time.She did find a wrapper from the first box (lot number aw2098 and expiry date apr2022).She did not know what it means but next to that it says s 05/10.She says on the bottom left of the individual packaging she sees paa115871.The sample of the product was available to be returned, she had 2 unused wraps left of the second box.She had an individual wrapper left of the first box.Everything else had been thrown away.She was real excited about the product because she had real bad menstrual cramps and they did help her a lot so she thought it was really weird that she got burned.She was upset that she couldn't use them anymore because they helped her but she didn't expect to have this kind of reaction.Action taken for thermacare heatwrap was permanently discontinued on 07sep2020.Outcome of events was not recovered.On (b)(6)2020, according to the product quality complaint group: complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch cw9498 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: after a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this batch.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/negligible-minor for menstrual 8hr heat wrap products.Site sample status was not received.On (b)(6)2020, additional investigational results from the product quality complaint included : complaint sub-class: adverse event/serious/unknown.Summary of investigation: batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related was no.Final confirmation status was not confirmed.On (b)(6)2020, the product quality complaint group provided updated trend information: complaint sub-class: adverse event/serious/unknown: lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the albany site requiring an evaluation for this lot.A visual examination was performed to identify a potential trend for the subclass and lot number, per sop-# complaint trending guideline, effective (b)(6)2020.Refer to the 36-month attached trend chart aw2098.On the basis of this evaluation, a trend does not exist for this batch.There was deviation from sop-#, complaint trending guidelines, effective (b)(6)2020 in which the trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not how an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual products, refer to the 36-month attached trend chart for adverse event menstrual (b)(6)2017 to (b)(6)2020.There is no further action required.There was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Site sample status was not received.On (b)(6)2020, the product quality complaint group provided the following investigation results that yielded no product quality issues.Product: thermacare menstrual.Device lot number: cw9498 and aw2098.Expiration date: dec2022 and apr2022.Complaint sub-class: adverse event/serious/unknown.Reasonably suggest device malfunction: yes.Severity of harm: s3.Site sample status: not received.Summary of investigation: the manufacturing site reported the dhr, reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.Customer reported patient had large red burns from where the product was on her stomach.She has bad burns from where the cells are, she has 8 different burns from each of the 8 cells, there are 2 that are more red and inflamed and more puffed up, she says they feel raised and inflamed for thermacare menstrual heatwraps.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures above the upper specification limit.Root cause/capa: process related?: n/a; final confirmation status: not confirmed; vendor related?: no; root cause category: non-assignable (complaint not confirmed).Conclusion: based on the complaint narrative, the manufacturing site reported the dhr, reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch thermal records, the root cause category is non-assignable and complaint cannot be confirmed as a manufacturing quality defect.The batch thermal results met all product release criteria.The consumer reported she experienced, eight burns, two of the burns were worse than the others after using thermacare heat wrap for 8 hours.The cause of the consumers burns, after usage of thermacare heat wrap, is inconclusive since review of the records does not provide evidence to support a defective product.The product effect may vary with each individual.Customer reported patient had large red burns from where the product was on her stomach.She has bad burns from where the cells are, she has 8 different burns from each of the 8 cells, there are 2 that are more red and inflamed and more puffed up, she says they feel raised and inflamed for thermacare menstrual heatwraps.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.This dhr has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving wrap temperatures above the upper specification limit.Follow-up (15sep2020): follow-up attempts are completed.No further information is expected.Follow-up (14sep2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (16sep2020): new information received from the product quality complaint group includes investigational results.Follow up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from the product quality complaint group includes updated trend information.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: evaluation code method - historical data analysis was added.Follow-up (13nov2020): new information received from the product quality complaint group included: additional investigation results.Follow-up attempts are completed.No further information is expected.
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Search Alerts/Recalls
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