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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Second degree burns.Nerve damage.Case description: this is a spontaneous report from a non-clinical-study program, thermacare (b)(4) page.A contactable consumer reported a female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the consumer reported "do not use, my sister had 2nd degree burns and nerve damage and has suffered for 1.5 years with no meds touching the pain.She did not even leave on as long as the package said." action taken with the product was unknown.At the time of the report, clinical outcome of the event was unknown.No follow up attempts possible.No further information expected.Company comment: based on the available information, the company cannot exclude a possible contribution of the suspect device product (thermacare heatwrap) to the events of 2nd degree burns and nerve damage for 1.5 years.This case is medically assessed as serious and reportable (initial 30-day report).

Manufacturer Narrative

There was no reasonable suggestion of device malfunction.A sample was not received at the time.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.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.

Event Description

Event verbatim [preferred term].2nd degree buns [burns second degree], nerve damage [nerve injury].Narrative: this is a spontaneous report from a pfizer-sponsored program, thermacare facebook page.A contactable consumer reported a female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the consumer reported "do not use my sister had 2nd degree burns and nerve damage and has suffered for 1.5 years with no meds touching the pain.She did not even leave on as long as the package said." action taken with the product was unknown.At the time of the report, clinical outcome of the event was unknown.According to product quality complaint group: there was no reasonable suggestion of device malfunction.A sample was not received at the time.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.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.Follow-up (16apr2020): new information from the product quality complaint group includes: investigation results.No follow up attempts possible.No further information is expected.

• 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: 4512665
• MDR Text Key: 21452789
• Report Number: 1066015-2015-00003
• 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: Consumer,consumer
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: 01/30/2015
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention