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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Skin Tears (2516); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burned my back and ripped the skin off [thermal burn].Burned my back and ripped the skin off [skin exfoliation].Case description: this is a spontaneous report from (b)(6) from a contactable consumer.A patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history was not reported.The patient's concomitant medications were not reported.The patient reported "they burned my back and ripped the skin off" on an unspecified date with outcome of unknown.The action taken with thermacare heatwrap was unknown.No follow up attempts possible.No further information expected.Company clinical evaluation comment: based on the information provided, the events thermal burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Event verbatim [preferred term], burned my back and ripped the skin off [thermal burn], burned my back and ripped the skin off [skin exfoliation].Narrative: this is a spontaneous report from a pfizer-sponsored program thermacare facebook page from a contactable consumer.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported "they burned my back and ripped the skin off" on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality complaint group: reasonably suggest device malfunction: no.An investigation 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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No 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 and visual inspection, to ensure product quality.Lot trend assmt.& rationale: no lot trending performed on unknown lot number.Site sample status was not received.Follow-up (16apr2020): new information received from the product quality complaint group included investigational results.No follow up attempts possible.No further information expected., comment: based on the information provided, the events thermal burn and skin exfoliation as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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 further investigations or actions is suggested at this time.

Manufacturer Narrative

An investigation 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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No 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 and visual inspection, to ensure product quality.Lot trend assmt.& rationale: no lot trending performed on unknown lot number.

• 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: 5315258
• MDR Text Key: 34019894
• Report Number: 1066015-2015-00159
• 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
• Type of Report: Initial,Followup
• Report Date: 12/12/2015

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: 12/12/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: 12/12/2015
• Supplement Dates FDA Received: 04/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention