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| Lot Number AA2381 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)
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| Patient Problem
Partial thickness (Second Degree) Burn (2694)
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| Event Date 12/04/2019 |
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Event Type
Injury
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Event Description
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2 2 euro-coin-sized burn blisters in shoulder/neck area [burns second degree].Case narrative: this is a spontaneous report from a contactable pharmacist.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number aa2381, from (b)(6) 2019 to (b)(6) 2019 for an unspecified indication.The patient medical history was not reported.There were no concomitant medications.The patient experienced 2 2 euro-coin-sized burn blisters in shoulder/neck area on (b)(6) 2019 with outcome of unknown.The action taken with thermacare heatwrap was permanently withdrawn.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] 2 2 euro-coin-sized burn blisters in shoulder/neck area [burns second degree] , unpleasantly warm/ too hot [device issue].Case narrative:this is a spontaneous report from a contactable pharmacist and consumer via product quality complaints.A 44-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number aa2381, from (b)(6) 2019 for an unspecified indication.The patient's medical history was not reported.There were no concomitant medications.The patient experienced 2 2 euro-coin-sized burn blisters in shoulder/neck area on (b)(6) 2019.The patient, who supposedly was on a walk, discovered the wrap felt unpleasantly warm, which means it felt too hot.She could not remove the wrap as she was on the way.When removing the wraps, the burn blisters were there.The action taken with thermacare heatwrap was permanently withdrawn on 04dec 2019.The outcome of the events was unknown.Product quality complaints provided the following investigation 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.Consumer reports wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Product quality complaints provided severity of harm rating as s3.There was reasonable suggestion of device malfunction.Follow-up (11dec2019 and 16dec2019): new information from product quality complaints and from a contactable consumer via product quality complaints includes: additional event details, new event (unpleasantly warm/ too hot), and investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn blisters" "unpleasantly warm/ too hot" as described are considered serious bodily injury potentially 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.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn blisters" "unpleasantly warm/ too hot" as described are considered serious bodily injury potentially 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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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 wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Product quality complaints provided severity of harm rating as s3.There was reasonable suggestion of device malfunction.
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Manufacturer Narrative
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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 wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Product quality complaints provided severity of harm rating as s3.There was reasonable suggestion of device malfunction.
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Event Description
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Event verbatim [preferred term] 2 2 euro-coin-sized burn blisters in shoulder/neck/back area [burns second degree] , unpleasantly warm/ too hot [device issue] ,.Case narrative:this is a spontaneous report from a contactable pharmacist and consumer via product quality complaints.A 44-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number aa2381, from (b)(6) 2019 from 11am to 6:50 pm for back pain.The patient's medical history was not reported.There were no concomitant medications.The patient had not used thermacare heatwrap before.The patient experienced 2 2 euro-coin-sized burn blisters in shoulder/neck/back area on 04dec2019.The patient, who supposedly was on a walk, discovered the wrap felt unpleasantly warm, which means it felt too hot.She could not remove the wrap as she was on the way.When removing the wraps, the burn blisters were there.The pharmacist reported that, "the heatwrap was applied by my colleague.After 2 hours an hour in the fresh air - it got a little hot.After that it was normal warm again.The blister was found while removal.Normal treatment with a suitable ointment." no surgical intervention was needed and there was no long-term sequelae.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2019.The outcome of the events was recovered on (b)(6) 2019.Product quality complaints provided the following investigation 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.Consumer reports wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Product quality complaints provided severity of harm rating as s3.There was reasonable suggestion of device malfunction.Follow-up (11dec2019 and 16dec2019): new information from product quality complaints and from a contactable consumer via product quality complaints includes: additional event details, new event (unpleasantly warm/ too hot), and investigation results.Follow-up (03jan2020): new information received from the same contactable pharmacist includes: demographic data; suspect drug data (indication added); event data and event details (outcome and end date added).Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "burn blisters" "unpleasantly warm/ too hot" as described are considered serious bodily injury potentially 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.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] 2 2 euro-coin-sized burn blisters in shoulder/neck/back area [burns second degree], unpleasantly warm/ too hot [device issue], , narrative: this is a spontaneous report from a contactable pharmacist and consumer via product quality complaints.A 44-year-old female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung), device lot number aa2381, expiry date: 31dec2021, on (b)(6) 2019 from 11am to 6:50 pm for back pain.The patient's medical history was not reported.There were no concomitant medications.The patient had not used thermacare heatwrap before.The patient experienced 2 2 euro-coin-sized burn blisters in shoulder/neck/back area on (b)(6) 2019 6:50 pm.The patient, who supposedly was on a walk, discovered the wrap felt unpleasantly warm, which means it felt too hot.She could not remove the wrap as she was on the way.When removing the wraps, the burn blisters were there.The pharmacist reported that, "the heatwrap was applied by my colleague.After 2 hours an hour in the fresh air - it got a little hot.After that it was normal warm again.The blister was found while removal.Normal treatment with a suitable ointment." no surgical intervention was needed and there was no long-term sequelae.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2019.The outcome of the events was recovered on (b)(6) 2019.According to product quality complaints, lot aa2381 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (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 wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaint intake, triage and investigation (citi) customizable search, there is not a trend identified for the subclass of too hot.Refer to attached trending chart flex xl ae serious unknown (b)(6) 2016 to (b)(6)2019.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates (b)(6)2019 and (b)(6)2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.Product quality complaints provided severity of harm rating as s3.There was reasonable suggestion of device malfunction.Follow-up (11dec2019 and 16dec2019): new information from product quality complaints and from a contactable consumer via product quality complaints includes: additional event details, new event (unpleasantly warm/ too hot), and investigation results.Follow-up (03jan2020): new information received from the same contactable pharmacist includes: demographic data; suspect drug data (indication added); event data and event details (outcome and end date added).Follow-up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from product quality complaint group includes: updated trend information.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Lot aa2381 is the only lot within the scope of this investigation.Thermacare lots are produced as individual lots.The device history record (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 wrap "get too hot." the cause of the consumer stating the wrap becoming too hot is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaint intake, triage and investigation (citi) customizable search, there is not a trend identified for the subclass of too hot.Refer to attached trending chart flex xl ae serious unknown (b)(6)2016 to (b)(6)2019.This investigation was reopened to change information in the lot trend assessment & rationale and expedite trend assessment & rationale sections.This change was due to a deviation found from (b)(4), complaint trending guidelines, effective dates (b)(6) 2019 and (b)(6)2020.A notification of nonconformance was opened (b)(4).This deviation will not change the conclusion of the investigation.
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Search Alerts/Recalls
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