MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Material Integrity Problem (2978)

Patient Problems Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 02/05/2019

Event Type  Injury  

Event Description

Event verbatim (preferred term) skin burn/burn blisters (burns second degree).Case narrative: this is a spontaneous report from a contactable pharmacist received via customer care center.A (b)(6) years-old (reported as 55 - 60 years) female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number and expiration date unknown), from (b)(6) 2019 to (b)(6) 2019 at once daily for warmth treatment.The patient medical history and concomitant medications were not reported.The patient experienced skin burn with burn blisters on (b)(6) 2019.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.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 burns second degree 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 burns second degree 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.

Event Description

Event verbatim [preferred term] skin burn/burn blisters [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable pharmacist received via customer care center.A 58-year-old (reported as 55 - 60 years) female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number and expiration date unknown), from (b)(6) 2019 to (b)(6) 2019 at once daily for warmth treatment.The patient medical history and concomitant medications were not reported.The patient experienced skin burn with burn blisters on (b)(6) 2019.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.As of (b)(6) 2019, the product quality complaint (pqc) group investigation results stated the root cause category is non assignable (complaint not confirmed as a quality defect).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of nsw 12 hour for germany products.The 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.The following batches were produced for the germany market: h66740, j01199, j36122, j67196, l16815, l16857, l31419, l44146, l49951, l92682, m13368, m61524, m87697, mn15262, n33570, n49174, n73395, r15191, r47299, r97319, s16661, s16679, s23830, s23831, t38964, t38966, t48910, t48938, t48947 and t69820.There were no quality issues identified in these batches.Follow-up (b)(6) 2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event of burns second degree 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of burns second degree 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of nsw 12 hour for germany products.The 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.The following batches were produced for the germany market: h66740, j01199, j36122, j67196, l16815, l16857, l31419, l44146, l49951, l92682, m13368, m61524, m87697, mn15262, n33570, n49174, n73395, r15191, r47299, r97319, s16661, s16679, s23830, s23831, t38964, t38966, t48910, t48938, t48947 and t69820.There were no quality issues identified in these batches.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8325217
• MDR Text Key: 135707414
• Report Number: 1066015-2019-00032
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR