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| Lot Number T65624 |
| Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Numbness (2415); Burn, Thermal (2530); No Code Available (3191)
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| Event Date 03/03/2020 |
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Event Type
Injury
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Event Description
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Black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not [application site burn] , skin was numb under the product after removing it [hypoaesthesia] , the patient read usage instructions on thermacare before she used the product/she did not check her skin under the product while wearing thermacare [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for her mom.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: t65624, expiration date: nov2020, udi#: (b)(4), via an unspecified route of administration from (b)(6) 2020 to (b)(6) 2020 for 6- 7 hours per day for back pain that couldn't stand up.Medical history included arthritis in her hands and accident from an unknown date and unknown if ongoing.There were no concomitant medications.There was no investigation assessment.The reporter stated the patient was in the hospital on sunday in the er because she picked up her granddaughter and her back hurt.She was seen for back pain.The reporter stated her mom (patient) had an accident on sunday and she bought the thermacare and it burned her back on (b)(6) 2020, clarifying the burn located on her lower back right before her butt and it was the black burn that was the size of the thermacare product.She stated it almost got bloody a little bit but it did not.It was painful.Skin was numb under the product after removing it.She stated it looked like when you used an iron on clothes and burned it, but it didn't.Burn was reported as worsened.The patient had not received any treatment from a physician.She was using vasoline on her own so it didn't burn.The patient was currently not under the care of a physician for any medical condition.It was reported she felt she had arthritis in her hands but didn't know.The skin tone was classified as medium.The patient did not have sensitive skin or abnormal skin conditions.The patient hadn't used thermacare previously but she had previously used other heat products for pain relief for 3-5 hours and hadn't experienced a problem/symptom with the product.The patient read usage instructions on thermacare before she used the product and she was sleeping while wearing the product.The patient did not engage in exercise while using the product and she did not check her skin under the product while wearing thermacare.For specify treatment/intervention, the patient felt like it would be there for ever, looking like a "tramp" tattoo.It was considered there was a reasonable possibility that the event burn was related to the device.The sample of the product was available to be returned.The last action taken in response to the events was permanently discontinued on (b)(6) 2020.The outcome of the event "black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not" was not recovered, of the other events was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events application site burn, hypoaesthesia and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not [application site burn] , skin was numb under the product after removing it [hypoaesthesia] , the patient read usage instructions on thermacare before she used the product/she did not check her skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reporting for her mom.A 54-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: t65624, expiration date: nov2020, udi#: (b)(4), from (b)(6) 2020 for 6-7 hours per day for back pain that couldn't stand up.Medical history included arthritis in her hands and accident from an unknown date and unknown if ongoing.There were no concomitant medications.There was no investigation assessment.The reporter stated the patient was in the hospital on sunday in the er because she picked up her granddaughter and her back hurt.She was seen for back pain.The reporter stated her mom (patient) had an accident on sunday and she bought the thermacare and it burned her back on (b)(6) 2020, clarifying the burn located on her lower back right before her butt and it was the black burn that was the size of the thermacare product.She stated it almost got bloody a little bit but it did not.It was painful.Skin was numb under the product after removing it.She stated it looked like when you used an iron on clothes and burned it, but it didn't.Burn was reported as worsened.The patient had not received any treatment from a physician.She was using vaseline on her own so it didn't burn.The patient was currently not under the care of a physician for any medical condition.It was reported she felt she had arthritis in her hands but didn't know.The skin tone was classified as medium.The patient did not have sensitive skin or abnormal skin conditions.The patient hadn't used thermacare previously but she had previously used other heat products for pain relief for 3-5 hours and hadn't experienced a problem/symptom with the product.The patient read usage instructions on thermacare before she used the product and she was sleeping while wearing the product.The patient did not engage in exercise while using the product and she did not check her skin under the product while wearing thermacare.For specify treatment/intervention, the patient felt like it would be there for ever, looking like a "tramp" tattoo.It was considered there was a reasonable possibility that the event burn was related to the device.The sample of the product was available to be returned.The last action taken in response to the events was permanently discontinued on (b)(6) 2020.The outcome of the event "black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not" was not recovered, of the other events was unknown.According to the product quality complaint group on (b)(6) 2020: batch t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.Follow-up (31mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events application site burn, hypoaesthesia and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.
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Manufacturer Narrative
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Batch: t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event / serious / unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.According to the product quality complaint group on 01sep2020 this investigation was reopened to add the results of the consumer return sample evaluation.Site sample was received at the site on 19mar2020.This evaluation will not change the conclusion of this complaint record.A full investigation is not required, complaint not confirmed.The root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not confirm the complaint for a burn.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Review of the batch device history record for this batch concludes all release requirements were met.Visual complete sample evaluation was completed on 04jun2020 the visual inspection of a retain sample included one carton and the two pouched wraps inside.There were no obvious defects found on carton or pouched wraps.Reserve sample testing was not required.Conclusion: no quality issues were identified upon the dhr review, 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 lot is not impacted by this complaint.Based on the complaint narrative, patient experienced burns injury with product use, which is inconclusive since review of records does not provide evidence to support defective product.Failure mode: burns, reasonably suggest device malfunction was reported as yes.Severity of harm: s3.
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Event Description
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Event verbatim [preferred term] black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not [application site burn], skin was numb under the product after removing it [hypoaesthesia], the patient read usage instructions on thermacare before she used the product/she did not check her skin under the product while wearing thermacare [intentional device misuse].Narrative: this is a spontaneous report from a contactable consumer reporting for her mom.A 54-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number: t65624, expiration date: nov2020, udi#: (b)(4), from on (b)(6) 2020 for 6-7 hours per day for back pain that couldn't stand up.Medical history included arthritis in her hands and accident from an unknown date and unknown if ongoing.There were no concomitant medications.There was no investigation assessment.The reporter stated the patient was in the hospital on sunday in the er because she picked up her granddaughter and her back hurt.She was seen for back pain.The reporter stated her mom (patient) had an accident on sunday and she bought the thermacare and it burned her back on (b)(6) 2020, clarifying the burn located on her lower back right before her butt and it was the black burn that was the size of the thermacare product.She stated it almost got bloody a little bit but it did not.It was painful.Skin was numb under the product after removing it.She stated it looked like when you used an iron on clothes and burned it, but it didn't.Burn was reported as worsened.The patient had not received any treatment from a physician.She was using vasoline on her own so it didn't burn.The patient was currently not under the care of a physician for any medical condition.It was reported she felt she had arthritis in her hands but didn't know.The skin tone was classified as medium.The patient did not have sensitive skin or abnormal skin conditions.The patient hadn't used thermacare previously but she had previously used other heat products for pain relief for 3-5 hours and hadn't experienced a problem/symptom with the product.The patient read usage instructions on thermacare before she used the product and she was sleeping while wearing the product.The patient did not engage in exercise while using the product and she did not check her skin under the product while wearing thermacare.For specify treatment/intervention, the patient felt like it would be there for ever, looking like a "tramp" tattoo.It was considered there was a reasonable possibility that the event burn was related to the device.The sample of the product was available to be returned.The last action taken in response to the events was permanently discontinued on 03mar2020.The outcome of the event "black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not" was not recovered, of the other events was unknown.According to the product quality complaint group on 31mar2020: batch: t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious / unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.According to the product quality complaint group on 01sep2020 this investigation was reopened to add the results of the consumer return sample evaluation.Site sample was received at the site on 19mar2020.This evaluation will not change the conclusion of this complaint record.A full investigation is not required, complaint not confirmed.The root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not confirm the complaint for a burn.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Review of the batch device history record for this batch concludes all release requirements were met.Visual complete sample evaluation was completed on 04jun2020.The visual inspection of a retain sample included one carton and the two pouched wraps inside.There were no obvious defects found on carton or pouched wraps.Reserve sample testing was not required.Conclusion: no quality issues were identified upon the dhr review, 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 lot is not impacted by this complaint.Based on the complaint narrative, patient experienced burns injury with product use, which is inconclusive since review of records does not provide evidence to support defective product.Failure mode: burns, reasonably suggest device malfunction was reported as yes.Severity of harm: s3.Follow-up attempts are completed.No further information is expected.Follow-up (31mar2020): new information received from product quality complaint group includes investigation results.Follow-up (04may2020): follow-up attempts are completed.No further information is expected.Follow-up (01sep2020): new information received from product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events application site burn, hypoaesthesia and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot / batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.According to the product quality complaint group on 01sep2020 this investigation was reopened to add the results of the consumer return sample evaluation.Site sample was received at the site on 19mar2020.This evaluation will not change the conclusion of this complaint record.A full investigation is not required, complaint not confirmed.The root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not confirm the complaint for a burn.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Review of the batch device history record for this batch concludes all release requirements were met.Visual complete sample evaluation was completed on 04jun2020 the visual inspection of a retain sample included one carton and the two pouched wraps inside.There were no obvious defects found on carton or pouched wraps.Reserve sample testing was not required.Conclusion: no quality issues were identified upon the dhr review, 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 lot is not impacted by this complaint.Based on the complaint narrative, patient experienced burns injury with product use, which is inconclusive since review of records does not provide evidence to support defective product.Failure mode: burns, reasonably suggest device malfunction was reported as yes.Severity of harm: s3.Site sample status was received at the site.Date samples were received: 19mar2020.Return sample evaluation: two wraps - one wrap shows evidence of wear.Cell packs are exhausted - no obvious defects.One wrap is inside sealed pouch.One pouch - (l) (b)(4)12/04; exp nov2020 07:02; pouch is sealed - no obvious defects.One carton - (l) t65624 12/04; exp nov2020 07:05.Carton is open.Three photo's were returned.One photo of a carton and two were of the consumer's back.Exped trend actions taken: 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-#.
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Event Description
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Event verbatim [preferred term].The patient read usage instructions on thermacare before she used the product/she did not check her skin under the product while wearing thermacare [intentional device misuse], black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not [application site burn], skin was numb under the product after removing it [hypoaesthesia], , narrative: this is a spontaneous report from a contactable consumer reporting for her mom.A 54-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip), device lot number: t65624, expiration date: nov2020, udi#: (b)(4), on (b)(6)2020 for 6-7 hours per day for back pain that couldn't stand up.Medical history included arthritis in her hands and accident from an unknown date and unknown if ongoing.There were no concomitant medications.There was no investigation assessment.The reporter stated the patient was in the hospital on sunday in the er because she picked up her granddaughter and her back hurt.She was seen for back pain.The reporter stated her mom (patient) had an accident on sunday and she bought the thermacare and it burned her back on (b)(6) 2020, clarifying the burn located on her lower back right before her butt and it was the black burn that was the size of the thermacare product.She stated it almost got bloody a little bit but it did not.It was painful.Skin was numb under the product after removing it.She stated it looked like when you used an iron on clothes and burned it, but it didn't.Burn was reported as worsened.The patient had not received any treatment from a physician.She was using vasoline on her own so it didn't burn.The patient was currently not under the care of a physician for any medical condition.It was reported she felt she had arthritis in her hands but didn't know.The skin tone was classified as medium.The patient did not have sensitive skin or abnormal skin conditions.The patient hadn't used thermacare previously but she had previously used other heat products for pain relief for 3-5 hours and hadn't experienced a problem/symptom with the product.The patient read usage instructions on thermacare before she used the product and she was sleeping while wearing the product.The patient did not engage in exercise while using the product and she did not check her skin under the product while wearing thermacare.For specify treatment/intervention, the patient felt like it would be there for ever, looking like a "tramp" tattoo.It was considered there was a reasonable possibility that the event burn was related to the device.The sample of the product was available to be returned.The last action taken in response to the events was permanently discontinued on (b)(6) 2020.The outcome of the event "black burn that was the size of the thermacare product.It almost got bloody a little bit but it did not" was not recovered, of the other events was unknown.According to the product quality complaint group on (b)(6) 2020: batch t65624 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history report (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support 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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Site sample status is not received.Severity of harm is s3.According to the product quality complaint group on 01sep2020 this investigation was reopened to add the results of the consumer return sample evaluation.Site sample was received at the site on 19mar2020.This evaluation will not change the conclusion of this complaint record.A full investigation is not required, complaint not confirmed.The root cause category is non assignable (complaint not confirmed as a quality defect).Evaluation of the return sample does not confirm the complaint for a burn.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "burned".The cause of the consumer stating the wrap causing a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Review of the batch device history record for this batch concludes all release requirements were met.Visual complete sample evaluation was completed on (b)(6) 2020.The visual inspection of a retain sample included one carton and the two pouched wraps inside.There were no obvious defects found on carton or pouched wraps.Reserve sample testing was not required.Conclusion: no quality issues were identified upon the dhr review, 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 lot is not impacted by this complaint.Based on the complaint narrative, patient experienced burns injury with product use, which is inconclusive since review of records does not provide evidence to support defective product.Failure mode: burns, reasonably suggest device malfunction was reported as yes.Severity of harm: s3.According to the product quality complaint group on 13oct2020: site sample status was received at the site.Date samples were received: 19mar2020.Return sample evaluation: two wraps - one wrap shows evidence of wear.Cell packs are exhausted - no obvious defects.One wrap is inside sealed pouch.One pouch - (l) t65624 12/04; exp nov2020 07:02; pouch is sealed - no obvious defects.One carton - (l) t65624 12/04; exp nov2020 07:05.Carton is open.Three photo's were returned.One photo of a carton and two were of the consumer's back.Exped trend actions taken: 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-#.Follow-up attempts are completed.No further information is expected.Follow-up (31mar2020): new information received from product quality complaint group includes investigation results.Follow-up (04may2020): follow-up attempts are completed.No further information is expected.Follow-up (01sep2020): new information received from product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (13oct2020): new information received from the product quality complaint group included updated trending information.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events application site burn, hypoaesthesia and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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