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

Lot Number F93052A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Peeling (1999); Scar Tissue (2060); Malaise (2359); Inadequate Pain Relief (2388); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2015

Event Type  Other  

Manufacturer Narrative

Company clinical evaluation comment based on the information provided, the event burn blister, skin exfoliation, and scab 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 events malaise, device ineffective and device· misuse are considered as associated with device use.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Got 2 actual blister burns on her back from that and rest were the little things,all made pretty distinctive marks [burns.Second degree], was not feeling well [malaise], it was not helping her (wife) problem anyhow [device ineffective], consumer used the expired product [device misuse], the skin came off/ peeled off [skin exfoliation], got little scabs [scab].Case description: this is a spontaneous report from a contactable consumer on behalf of his wife.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back and hip), device lot number f93052a, expiration date jan2015, from 2015 just for one night for back pain.The patient medical history included a fall and barely able to move.There were no concomitant medications.Past product history included (thermacare lower back and hip).The patient experienced 2 actual blister burns on her back from that and rest were the little things in 2015, all made pretty distinctive marks, was not feeling well.It was not helping her problem anyhow, she used the expired product, the skin came off/peeled off, and she got little scabs on an unspecified date.The action taken with thermae are heatwrap was unknown.The outcome of the events was resolving and the outcome of using an expired product was unknown.The consumer mentioned that she (wife) did not have any medical history in regards to the side effects.His wife skin tone was medium.She did not use any creams, rubs or gets under the wrap.She mentioned that she did use thermacare lower back and hip in the past and they get it all the time.She did not notice any defect on the wrap like cuts, tears, leaks or holes, it was like it always did.She did not change or modify the wrap in anyway.She did not use the wrap overnight or while sleeping; she used the wrap during day time.The reporter mentioned that she (wife) did not put the wrap in the microwave.She did use the wrap over healthy skin.She did use the wrap over the correct part of the body.She did not exercise while using the wrap; as she was barely able to move.She did not apply any pressure over the wrap.The reporter mentioned that she did not wear more than two layers of clothing over the wrap as it's very hot here.She did not sit or recline for a prolonged period of time; she sat normally, the reporter mentioned that he would not say that she got up and down, he didn't know.She used the wrap for partially one day, may be 5 or 6 hours.She did not use more than one wrap per day.She wore the wrap for around 5 hours approximately.When the reporter was asked did his wife feel that the heat wrap was getting too hot, he said "no" and further said that he took it (thermacare lower back and hip) off because it was not helping her (wife) problem anyhow.When reporter was asked about the size and location of burn and blisters, the reporter mentioned that it was facing her (wife) back; it is the left side, the lowest part of the wrap, it affected on her lower back.When reporter was asked that is there any drainage of pus from the burns and blisters, he said "not now" further mentioned that it was a blister and the skin came off but it healed very quickly.It was still healing but it did not cause itch.She actually had little scabs right now.When the reporter was asked if his wife experienced any associated symptoms like pain, fever, rash or swelling, he mentioned that the only thing she (wife) had was back pain that's why she was using thermacare lower back and hip.When asked about the degree of burn, the reporter mentioned that he did not know how he would describe it, two of them caused, two of those little round lob long things (thermacare lower back and hip) caused regular blister like burn blisters.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Past product history included thermacare heatwraps (thermacare lower back and hip) from an unspecified date for an unspecified indication with no adverse effect on (b)(6) 2015, the patient experienced 2 actual blister burns on the left side of her lower back (the lowest part covered by the heatwrap).In addition, it was reported "all made pretty distinctive marks", she was not feeling well, it was not helping her problem anyhow and she used an expired product.The reporter stated the skin came off/peeled off then she got little scabs, then healed.The reporter stated there was no drainage of pus, itching, pain, fever, rash or swelling.It was reported the patient did not feel the heatwrap was getting too hot.When asked about the degree of burn, the reporter mentioned that he did not know how he would describe it, two of them caused two of those little round lob long things (thermacare lower back and hip) caused regular blister like burn blisters.Action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2015.No hospitalization was required as a result of the events.Therapeutic measures received included an unspecified ointment.Clinical outcome of the events was resolved on an unspecified date in (b)(6) 2015 (reported as approximately 1 week to heal); the outcome of events device ineffective and using an expired product was unknown.The reporter mentioned that she (wife) did not have any medical history in regards to the side effects.His wife's skin tone was assessed as medium the patient did not have sensitive skin or any abnormal skin conditions.She did not use any creams, rubs or gels under the wrap.The patient did not notice any defects on the wrap like cuts, tears, leaks or holes, it was like it always did she read the instructions on the heatwrap prior to use.The patient did not change or modify the wrap in anyway she did not use the wrap overnight or while sleeping; she used the wrap during day time.The reporter mentioned that his wife did not put the wrap in the microwave and used the wrap over healthy skin.She only checked the skin under the heatwrap when she removed the product.She did use the wrap over the correct part of the body and did not exercise while using the wrap; as she was barely able to move.The patient did not apply any pressure over the wrap.The reporter mentioned that she did not wear more than two layers of clothing over the wrap as it's very hot here.She did not sit or recline for a prolonged period of time, she sat normally the reporter mentioned that he would not say that she got up and down, he didn't know.She used the wrap for partially one day, maybe 5 or 6 hours the patient did not use more than one wrap per day.She has not previously used other heat products for pain relief including electric heating pad, hot water bottle or microwave gel packs.Follow-up ((b)(6) 2015): new information received from a contactable consumer includes.Action taken with suspect product, suspect product start/stop dates, events onset date, no hospitalization required, therapeutic measures received and events outcome.Follow-up attempts completed.No further information expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017 ; 2127335544
• MDR Report Key: 4796115
• MDR Text Key: 24652737
• Report Number: 1066015-2015-00053
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2015
• Device Lot Number: F93052A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 05/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR