MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Tissue Breakdown (2681)

Event Date 10/30/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] welts line up perfectly with the discs/some of the welts were more feverish/her skin was broken in some cases/welts were painful/she would know the degree of her burn [thermal burn] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A(b)(6)-years-old (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip) (lot, expiration date and barcode are unavailable as patient did not have the wraps since discharged) from an unspecified date for pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously used thermacare heatwrap (thermacare neck, shoulder & wrist) for pain in her shoulder about 2 weeks ago ((b)(6) 2017) and experienced when she pulled off the wrap off, the wrap pulled off the top layer of the dermis that was scalded, the wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding, it had caused a blister, the blister was oozing and bleeding onto her shirt.The patient used a thermacare lower back and hip wrap on (b)(6) 2017.She reported that she had 11 welts from the charcoal discs in the wrap, the welts line up perfectly with the discs.Some of the welts were more feverish looking than others, her skin was broken in some cases and the welts were painful.She noticed the welts yesterday ((b)(6) 2017) when she arrived home from school.Treatment: declined any.She wanted to go to the doctor so she would know the degree of her burn, but as a teacher she did not have time to go.She reported it was tender back there and she was trying not to lean against anything.Reported the wraps were very comfortable to wear and the wrap stayed wear you put it.She had the wrap and the wrapper at home.She was not sure if there was a warning if it could burn elderly people.Reported the website said the product may result in burning if used on people 55 and older.This was the first time she heard of anything like that.She had been using thermacare heat wraps off and on for years.Events outcome 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 "welts line up perfectly with the discs/some of the welts were more feverish/her skin was broken in some cases/welts were painful/she would know the degree of her burn" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This event is medically assessed as associated with the use of the device., comment: based on the information provided, the event "welts line up perfectly with the discs/some of the welts were more feverish/her skin was broken in some cases/welts were painful/she would know the degree of her burn" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This event is medically assessed as associated with the use of the device.

Manufacturer Narrative

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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] welts line up perfectly with the discs/some of the welts were more feverish/her skin was broken in some cases/welts were painful/she would know the degree of her burn [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 64-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain.The patient medical history and concomitant medications were not reported.The patient previously used thermacare heatwrap (thermacare neck, shoulder & wrist) for pain in her shoulder about 2 weeks ago (b)(6) 2017 and when she pulled off the wrap off, the wrap pulled off the top layer of the dermis that was scalded, the wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding, it had caused a blister, the blister was oozing and bleeding onto her shirt.The patient used a thermacare lower back and hip wrap on (b)(6) 2017.She reported that she had 11 welts from the charcoal discs in the wrap, the welts line up perfectly with the discs.Some of the welts were more feverish looking than others, her skin was broken in some cases and the welts were painful.She noticed the welts yesterday (b)(6) 2017 when she arrived home from school.The patient declined any treatment.She wanted to go to the doctor so she would know the degree of her burn, but as a teacher she did not have time to go.She reported it was tender back there and she was trying not to lean against anything.Reported the wraps were very comfortable to wear and the wrap stayed wear you put it.She did not have the wraps or the cellophane wrappers handy to provide lot, expiration date and barcode.She discarded the boxes.She had the wrap and the wrapper at home.She was not sure if there was a warning if it could burn elderly people.Reported the website said the product may result in burning if used on people 55 and older.This was the first time she heard of anything like that.She had been using thermacare heat wraps off and on for years.The action taken in response to the event was unknown.Event outcome was unknown.According to the product quality complaint group: reasonably suggest device malfunction: no.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up (03apr2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event "welts line up perfectly with the discs/some of the welts were more feverish/her skin was broken in some cases/welts were painful/she would know the degree of her burn" as described was considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This 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.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 7008855
• MDR Text Key: 91307685
• Report Number: 1066015-2017-00157
• 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: 10/31/2017

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 47