|
|
| Lot Number R54931 |
| Device Problems
Difficult to Remove (1528); Use of Device Problem (1670)
|
| Patient Problems
Pain (1994); Partial thickness (Second Degree) Burn (2694)
|
| Event Date 12/10/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
Left a blood blister [blood blister], this one was so hard and painful to pull off/tried to pull it off slowly and it hurt so bad/yelled out at her husband when she tried to pull off the product/this new one really stuck to her [device adhesion issue], used the product on her lower back/only had it on her back for about 5 minutes before she tried to reposition it [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number r54931, expiration date sep2019, upc number: 305733015025, on (b)(6) 2017 at 1 heatwrap topically for low back strain.Medical history included car accident.There were no concomitant medications.The consumer stated she was in a car accident and was given a thermacare neck, wrist, and shoulder heatwrap because someone hit her car from behind.She went out and bought a box of the thermacare neck, wrist, and shoulder heatwraps and used the product on her lower back.She explained that with the new box she had bought, she tried to reposition the heatwrap after she had it on the lower back and it pulled so hard that it left a blood blister on (b)(6) 2017.She said that it also left a 3 by 3 inch reddened area on (b)(6) 2017.She described that the blood blister was a little spot and it was not as big as the adhesive area.It was like a small area, like someone pinched her.She stated that she yelled out at her husband when she tried to pull off the product.She said that the one she got from the pharmacy she had no problem with; this new one really stuck to her.She put vaseline on the reddened area to treat it and reported that the reddened area was gone.She did not understand why this one was so hard and painful to pull off.She said she tried to pull it off slowly and it hurt so bad that she had to pull it off fast.She said that if she had known that, she would not have bought it.She stated that she only had it on her back for about 5 minutes before she tried to reposition it and all of this happened.No relevant testing to report.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of "left a blood blister" was not resolved.The outcome of "3 by 3 inch red area" was resolved in 2017.The outcome of "used the product on her lower back" was resolved on (b)(6) 2017.The outcome of other events was unknown.Device was available for evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (26feb2019): follow-up attempts are completed.No further information is expected.Follow-up (11dec2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Company clinical evaluation comment: based on the information provided, the events of "bloody blisters" and "device adhesion issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "bloody blisters" and "device adhesion issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.
|
| |
|
Manufacturer Narrative
|
|
Conclusion: 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.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Batch/process record review:document review summary: batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degree c - 41.6 degree c).This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] left a blood blister [blood blister] , this one was so hard and painful to pull off/tried to pull it off slowly and it hurt so bad/yelled out at her husband when she tried to pull off the product/this new one really stuck to her [device adhesion issue] , used the product on her lower back/only had it on her back for about 5 minutes before she tried to reposition it [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 66-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number r54931, expiration date 30sep2019, upc number: (b)(4).On (b)(6) 2017 at 1 heatwrap topically for low back strain.Medical history included car accident.There were no concomitant medications.The consumer stated she was in a car accident and was given a thermacare neck, wrist, and shoulder heatwrap because someone hit her car from behind.She went out and bought a box of the thermacare neck, wrist, and shoulder heatwraps and used the product on her lower back.She explained that with the new box she had bought, she tried to reposition the heatwrap after she had it on the lower back and it pulled so hard that it left a blood blister on (b)(6) 2017.She said that it also left a 3 by 3 inch reddened area on (b)(6) 2017.She described that the blood blister was a little spot and it was not as big as the adhesive area.It was like a small area, like someone pinched her.She stated that she yelled out at her husband when she tried to pull off the product.She said that the one she got from the pharmacy she had no problem with; this new one really stuck to her.She put vaseline on the reddened area to treat it and reported that the reddened area was gone.She did not understand why this one was so hard and painful to pull off.She said she tried to pull it off slowly and it hurt so bad that she had to pull it off fast.She said that if she had known that, she would not have bought it.She stated that she only had it on her back for about 5 minutes before she tried to reposition it and all of this happened.No relevant testing to report.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of "left a blood blister" was not resolved.The outcome of "used the product on her lower back" was resolved on (b)(6) 2017.The outcome of other events was unknown.Device was available for evaluation.Product investigation results were as follows: conclusion: 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.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Batch/process record review:document review summary: batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degree c - 41.6 degree c).This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Additional information has been requested and will be provided as it becomes available.Follow-up (b)(4 2019): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up ((b)(6) 2019): new information received from a product quality complaints group includes product investigation summary results and updated expiration date.Company clinical evaluation comment based on the information provided, the events of "bloody blisters" and "device adhesion issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "bloody blisters" and "device adhesion issue" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.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.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Event Description
|
|
Event verbatim [preferred term].Left a blood blister [blood blister], this one was so hard and painful to pull off/tried to pull it off slowly and it hurt so bad/yelled out at her husband when she tried to pull off the product/this new one really stuck to her [device adhesion issue], used the product on her lower back/only had it on her back for about 5 minutes before she tried to reposition it [device use issue].Narrative: this is a spontaneous report from a contactable consumer reported for herself.A 66-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number r54931, expiration date 30sep2019, upc number: 305733015025, on (b)(6) 2017 at 1 heatwrap topically for low back strain.Medical history included car accident.There were no concomitant medications.The consumer stated she was in a car accident and was given a thermacare neck, wrist, and shoulder heatwrap because someone hit her car from behind.She went out and bought a box of the thermacare neck, wrist, and shoulder heatwraps and used the product on her lower back.She explained that with the new box she had bought, she tried to reposition the heatwrap after she had it on the lower back and it pulled so hard that it left a blood blister on (b)(6) 2017.She said that it also left a 3 by 3 inch reddened area on (b)(6) 2017.She described that the blood blister was a little spot and it was not as big as the adhesive area.It was like a small area, like someone pinched her.She stated that she yelled out at her husband when she tried to pull off the product.She said that the one she got from the pharmacy she had no problem with; this new one really stuck to her.She put vaseline on the reddened area to treat it and reported that the reddened area was gone.She did not understand why this one was so hard and painful to pull off.She said she tried to pull it off slowly and it hurt so bad that she had to pull it off fast.She said that if she had known that, she would not have bought it.She stated that she only had it on her back for about 5 minutes before she tried to reposition it and all of this happened.No relevant testing to report.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of "left a blood blister" was not resolved.The outcome of "used the product on her lower back/only had it on her back for about 5 minutes before she tried to reposition it" was resolved on (b)(6) 2017.Device was available for evaluation.Product investigation results were as follows: conclusion: 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.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Batch/process record review: document review summary: batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degree c - 41.6 degree c).This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.According to the product quality complaint group, for complaint sub-class: adhesion/fastening defect, suggest device malfunction was yes; severity of harm was s2.Root cause: process related was no; final confirmation status was not confirmed.Site sample status was not received.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Document review summary was as follows batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.The material records for nsw skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were two batches of sca used in the manufacturing of the batch, batches 2000818818 and 2000818819.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot-specific trend identified was no.An evaluation of the complaint confirms that this is the first complaint for the sub class adhesion/fastening defect received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 7.1.This result was below the upper control limit (ucl) of (b)(4) complaints per (b)(4) complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.This is not an expedited complaint.Conclusion was as follows the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps caused a "blood blister and left a 3 by 3 inch reddened area" is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.At the time the complaint was initially received the product was within expiration date; at the time this investigation was completed the product had expired (expired 30sep2019).The product quality for the batch is not impacted by this complaint.Follow-up (26feb2019): follow-up attempts are completed.No further information is expected.Follow-up (11dec2017): this follow-up report is being submitted to upgrade this case to a reportable medical device report.Follow-up (13nov2019): new information received from a product quality complaints group includes product investigation summary results and updated expiration date.Follow-up (19dec2019): follow-up attempts are completed.No further information is expected.Follow-up (05aug2020): new information received from a product quality complaints group includes investigation results.Follow-up attempts are completed.No further information is expected.
|
| |
|
Manufacturer Narrative
|
|
Conclusion: 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.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.Batch/process record review:document review summary: batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degree c - 41.6 degree c).This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Root cause: process related was no; final confirmation status was not confirmed.Site sample status was not received.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Document review summary was as follows batch r54931 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.The material records for nsw skin contact adhesive laminate (sca); material number r000006147 were reviewed.There were two batches of sca used in the manufacturing of the batch, batches 2000818818 and 2000818819.There were no raw material incident forms completed for these batches of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch involving wrap adhesion defects.Lot-specific trend identified was no.An evaluation of the complaint confirms that this is the first complaint for the sub class adhesion/fastening defect received at the site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 7.1.This result was below the upper control limit (ucl) of (b)(4) complaints per (b)(4) complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.This is not an expedited complaint.Conclusion was as follows the root cause category is non assignable (complaint not confirmed).After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps caused a "blood blister and left a 3 by 3 inch reddened area¿ is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description.At the time the complaint was initially received the product was within expiration date; at the time this investigation was completed the product had expired (expired 30sep2019).The product quality for the batch is not impacted by this complaint.
|
| |
|
Search Alerts/Recalls
|
|
|
