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

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Rash (2033); Sleep Dysfunction (2517); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Company clinical eval comment: based on the info provided, the event thermal burn, blister, and device misuse 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.The other events insomnia, rash, pain, and product quality issue are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

First time he used had burn and second time he got blisters [thermal burn].First time he used had burn and second time he got blisters [blister] used the wrap directly against the skin/he did not check under the wrap [device misuse].He could not sleep on his left hand side [insomnia].Got the rashes [rash].Hurts a lot [pain].It was all burped out, like a quarter size [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) asian male consumer started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for back ache.Relevant medical history and concomitant medications were not reported.The consumer stated he used the wrap directly against the skin and he did not check under the wrap on an unspecified date.The consumer experienced first time he used heatwrap he had burn and second time he got blisters, he could not sleep on his left hand side, got the rashes, and it hurts a lot on an unspecified date.The consumer also reported the heatwrap was 'all burped out, like a quarter size".He mentioned that there were no defects on the wrap like cuts, tears, holes, leaks.He mentioned that there were no change or he did not modify the wrap in any way.He mentioned that he did not feel that wrap was getting too hot.Consumer added that he did not put the wrap in the microwave.Consumer did not use the wrap overnight or while sleeping.He used the wrap over healthy skin.He used the wrap over the correct part of the body.He did not overlap the wrap.He did not exercise while using the wrap.He added that he did not apply any pressure over the wrap.He did not wear more than two layers of clothing over the wrap.He did not sit or recline for a prolonged period of time.He mentioned that on an average, he wears wrap for 8 hours.The action taken in response to the events for thermacare heatwrap was unk.Therapeutic measures taken as a result of the events included using neosporin as treatment.The outcome of the events was unk.Additional info has been requested and will be provided as it becomes available.

Manufacturer Narrative

Reasonably suggest device malfunction was no, severity of harm was not applicable and site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, 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 root cause category is nonassignable (complaint not confirmed as a quality defect).The manufacturing operations employ quality control procedures include process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.

Event Description

Event verbatim [preferred term] used the wrap directly against the skin/ he did not check under the wrap [intentional device misuse], first time he used had burn and second time he got blisters [thermal burn], first time he used had burn and second time he got blisters [blister], he could not sleep on his left hand side [insomnia], got the rashes [rash], hurts a lot [pain], it was all burped out, like a quarter size [device issue] narrative: this is a spontaneous report from a contactable consumer.A 67-year-old male consumer started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for back ache.Relevant medical history and concomitant medications were not reported.The consumer stated he used the wrap directly against the skin and he did not check under the wrap on an unspecified date.The consumer experienced first time he used heatwrap he had burn and second time he got blisters, he could not sleep on his left hand side, got the rashes, and it hurts a lot on an unspecified date.The consumer also reported the heatwrap was "all burped out, like a quarter size." he mentioned that there were no defects on the wrap like cuts, tears, holes, leaks.He mentioned that there were no change or he did not modify the wrap in any way.He mentioned that he did not feel that wrap was getting too hot.Consumer added that he did not put the wrap in the microwave.Consumer did not use the wrap overnight or while sleeping.He used the wrap over healthy skin.He used the wrap over the correct part of the body.He did not overlap the wrap.He did not exercise while using the wrap.He added that he did not apply any pressure over the wrap.He did not wear more than two layers of clothing over the wrap.He did not sit or recline for a prolonged period of time.He mentioned that on an average, he wears wrap for 8 hours.The action taken in response to the events for thermacare heatwrap was unknown.Therapeutic measures taken as a result of the events included using neosporin as treatment.The outcome of the events was unknown.Investigations results from product quality complaints (pqc) group includes: reasonably suggest device malfunction was no, severity of harm was not applicable and site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, 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 root cause category is nonassignable (complaint not confirmed as a quality defect).The manufacturing operations employ quality control procedures include process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up attempts are completed.No further information is expected.Followup (b)(6) 2015: follow-up attempts completed.No further information expected.Follow-up (b)(6) 2020: new information received from a product complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the events thermal burn, blister, and device misuse 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.The other events insomnia, rash, pain, and product quality issue are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany, ga GA
• MDR Report Key: 5006580
• MDR Text Key: 23264123
• Report Number: 1066015-2015-00101
• 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: Followup
• Report Date: 08/03/2015

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: Not provided
• Initial Date FDA Received: 08/12/2015
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68