MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FLEXIBLE USE XL; DISPOSABLE PACK, HOT

Lot Number X63275

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 02/10/2020

Event Type  Injury  

Event Description

Large-area burns including burn blisters at whole shoulder- and neckarea [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable lawyer.The attorney reports by way of a claim letter that a female patient of an unspecified age started to receive thermacare heatwrap (thermacare flexible use xl), device lot number x63275, expiration date sep2021, from (b)(6) 2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient previously took thermacare heatwraps and experienced no adverse event.The patient experienced large-area burns including burn blisters at whole shoulder- and neckarea on (b)(6) 2020.It was reported that some red round lesions in the neck, estimated size about 1-2 cm, distance to each other the same or less.Some lesions were just red with intact skin.In some lesions, it seemed that the membrane of a previous blister was partly detached, the part now revealed was in lighter red, it was surronded by a darker circle.The lesions seemed not to be elevated or deepened." the action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

There was reasonable suggestion of device malfunction with severity of harm: s3.Site sample status: not received.Batch x63275 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "had burns and blisters after using the product." the cause of the consumer developing " burns and blisters after using the product" is inconclusive since review of records does not provide evidence to support the 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.Document review summary: batch x63275 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 degrees c - 41.6 degrees c) for the batch per spec-27465; effective date: 18july2018.This batch reviewed from a manufacturing perspective.There were no investigations associated with this batch for adverse event/serious/unknown.A trend does not exist for this lot complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.Per sop-105746, complaint trending guideline, effective 24feb2020, the complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 5 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this lot.A trend was not identified.

Event Description

Event verbatim [preferred term] large-area burns including burn blisters at whole shoulder- and neck area [burns second degree], narrative: this is a spontaneous report from a contactable lawyer.The attorney reports by way of a claim letter that a female patient of an unspecified age started to receive thermacare heatwrap (thermacare flexible use xl), device lot number x63275, expiration date sep2021, from 10feb2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient previously used thermacare heatwraps and experienced no adverse event.The patient experienced large-area burns including burn blisters at whole shoulder- and neck area on (b)(6) 2020.It was reported that "attached fotos showed some red round lesions in the neck, estimated size about 1-2 cm, distance to each other the same or less.Some lesions were just red with intact skin.In some lesions, it seemed that the membrane of a previous blister was partly detached, the part now revealed was in lighter red, it was surrounded by a darker circle.The lesions seemed not to be elevated or deepened." the action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product quality complaints provided the following investigation results: there was reasonable suggestion of device malfunction with severity of harm: s3.Site sample status: not received.Batch x63275 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "had burns and blisters after using the product." the cause of the consumer developing "burns and blisters after using the product" is inconclusive since review of records does not provide evidence to support the 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.Document review summary: batch x63275 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 degrees c - 41.6 degrees c) for the batch per spec-27465; effective date: 18july2018.This batch reviewed from a manufacturing perspective.There were no investigations associated with this batch for adverse event/serious/unknown.A trend does not exist for this lot complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.Per sop-105746, complaint trending guideline, effective 24feb2020, the complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 5 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this lot.A trend was not identified.Follow-up (b)(6) 2020: new information received from product quality group includes investigation results.

Manufacturer Narrative

There was reasonable suggestion of device malfunction with severity of harm: s3.Site sample status was not received.Batch x63275 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "had burns and blisters after using the product." the cause of the consumer developing "burns and blisters after using the product" is inconclusive since review of records does not provide evidence to support the 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 assessment and 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.Per (b)(4), complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 5 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this lot.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.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/serious/unknown for flexible use xl products.Refer to the 36-month trend chart attachment flexible use xl adverse event serious unknown (b)(6) 2017 to (b)(6) 2020.No further action required.There was deviation from (b)(4), 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 (b)(4), action item (b)(4).

Event Description

Event verbatim [preferred term].Large-area burns including burn blisters at whole shoulder- and neck area [burns second degree].Narrative: this is a spontaneous report from a contactable lawyer.The attorney reports by way of a claim letter that a female patient of an unspecified age started to receive thermacare heatwrap (thermacare flexible use xl), device lot number x63275, expiration date sep2021, from (b)(6) 2020 for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient previously used thermacare heatwraps and experienced no adverse event.The patient experienced large-area burns including burn blisters at whole shoulder- and neck area on (b)(6) 2020.It was reported that "attached fotos showed some red round lesions in the neck, estimated size about 1-2 cm, distance to each other the same or less.Some lesions were just red with intact skin.In some lesions, it seemed that the membrane of a previous blister was partly detached, the part now revealed was in lighter red, it was surrounded by a darker circle.The lesions seemed not to be elevated or deepened." the action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product quality complaints provided the following investigation results: there was reasonable suggestion of device malfunction with severity of harm: s3.Site sample status was not received.Batch x63275 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "had burns and blisters after using the product." the cause of the consumer developing "burns and blisters after using the product" is inconclusive since review of records does not provide evidence to support the 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 assessment and 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.Per (b)(4), complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend by calculating the complaints per million produced (cpmp) of the subclass.The calculated cpmp result of 5 was below the upper control limit (ucl) of 33.9 for the subclass.On the basis of this evaluation, a trend does not exist for this lot.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.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/serious/unknown for flexible use xl products.Refer to the 36-month trend chart attachment flexible use xl adverse event serious unknown (b)(6) 2017 to (b)(6) 2020.No further action required.There was deviation from (b)(4), 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 (b)(4), action item (b)(4).Follow-up (13may2020): new information received from product quality group includes investigation results.Follow-up (13oct2020): new information received from the product quality complaint group includes updated trend information.

• Brand Name: THERMACARE FLEXIBLE USE XL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9922408
• MDR Text Key: 189032163
• Report Number: 1066015-2020-00090
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Lot Number: X63275
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/21/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention