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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT
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PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT Back to Search Results
Lot Number W24913
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Skin Irritation (2076); Burning Sensation (2146); Discomfort (2330); Partial thickness (Second Degree) Burn (2694)
Event Date 09/18/2019
Event Type  Injury  
Event Description
Event verbatim [preferred term] burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble [burns second degree] , read the usage instructions on thermacare before using the product/ not check the skin under the product while wearing thermacare [intentional device misuse] , thermacare lower back & hip for left hip sciatic nerve pain [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A (b)(6)-year-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w24913, expiration date mar2021, upc number: 305733010037, from (b)(6) 2019 at about 8am to 4pm for 8 hours at 1 wrap for left hip sciatic nerve pain.There were no medical history and no concomitant medications.The patient was currently not under the care of a physician for any medical condition.The patient classified her skin tone as medium, she did not have sensitive skin or abnormal skin conditions.The patient previously used thermacare heatwrap for unknown indication 6-8 months ago for varies time and experienced no adverse effect.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) at varies time and experienced no adverse effect.The patient stated she was calling about the recall on thermacare heat wraps.The patient stated that she had a burn from wearing thermacare lower back and hip.The patient stated she just used it this one day on (b)(6) 2019.She used it from about 8am to 4pm.That was when she started to notice the discomfort.Around 4pm after wearing it for 8 hours was when she noticed burning and stinging.The patient stated it was red and blistered with a bubble.The patient stated that she had been using them for years.That's why she was surprised that this happened.She was unsure if she would continue to use the product because she was afraid to now.The patient stated she was trying to fix the soreness and everything, that there was a burn there.The version of thermacare she was using when she experienced the symptoms was back and hip, and the color of the box she purchased was red.There was product remaining.The patient stated it was attached to itself.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient did read the usage instructions on thermacare before she used the product, but she did not check her skin under the product while wearing thermacare.She was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the symptoms was experienced.The patient did not consult a healthcare professional for the symptoms.The patient stated that it was getting better but that it was still there.The patient stated that still had the burn, so she had not recovered completely.The packaging was sealed and intact.The sample of the product was not available to be returned.The action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6) 2019.Therapeutic measures were taken as a result of burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble which included put lotion on it and tried to air it out.The outcome of event burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble was recovering.The outcome of the other events was unknown.The reporter provided malfunction as yes.The reporter considered there is a reasonable possibility that ae burn is related to the device.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burns second degree" and "intentional device misuse" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burns second degree" and "intentional device misuse" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.
 
Event Description
Event verbatim [preferred term] burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble forming [burns second degree] , read the usage instructions on thermacare before using the product/ not check the skin under the product while wearing thermacare [intentional device misuse] , one "stone" on the top seemed to emit too much heat causing the burn [device issue] , thermacare lower back & hip for left hip sciatic nerve pain [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 69-year-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w24913, expiration date 31mar2021, upc number: 305733010037, from 18sep2019 at about 8am for 8 hours (also reported as for 7 hours) at 1 wrap for left hip sciatic nerve pain/ hip sciatic nerve.Medical history included ongoing post-menopausal.There were no concomitant medications.The patient was currently not under the care of a physician for any medical condition.The patient classified her skin tone as medium, she did not have sensitive skin or abnormal skin conditions.The patient previously used thermacare heatwraps for unknown indication 6-8 months ago for varies time for various date, used only for a few days for each issue and experienced no adverse effect.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) at varies time for a few days for each issue and experienced no adverse effect.The patient stated she was calling about the recall on thermacare heat wraps.The patient stated that she had a burn from wearing thermacare lower back and hip.The patient stated she just used it this one day on 18sep2019.She used it from about 8am to 4pm.That was when she started to notice the discomfort.Around 4pm after wearing it for 8 hours was when she noticed burning and stinging.The patient stated it was red and blistered with a bubble forming.Patient experienced red burn blister on left side of hip.The patient stated that the heat wrap was worn over undergarment, but one "stone" on the top seemed to emit too much heat causing the burn.The patient stated that she had been using them for years.That's why she was surprised that this happened.She was unsure if she would continue to use the product because she was afraid to now.The patient stated she was trying to fix the soreness and everything, that there was a burn there.The version of thermacare she was using when she experienced the symptoms was back and hip, and the color of the box she purchased was red.There was no product remaining.The patient stated it was attached to itself.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient did read the usage instructions on thermacare before she used the product, but she did not check her skin under the product while wearing thermacare.She was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the symptoms was experienced.The patient did not consult a healthcare professional for the symptoms.The packaging was sealed and intact.The sample of the product was not available to be returned.The action taken in response to the event for thermacare heatwrap was permanently discontinued on 18sep2019.The patient was not admitted to hospital due to the reported events.Therapeutic measures were taken as a result of burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble forming which included putting lotion on it and tried to air it out and applying antibiotic cream to prevent infection.The patient did not receive any treatment for the other events.Burn lasted 1 week until it healed in (b)(6) 2019.The outcome of events was recovered.The reporter provided malfunction as yes.The reporter considered there is a reasonable possibility that ae burn is related to the device.In product investigation report, severity of harm was reported as s3, root cause category (tier 1) as non-assignable (complaint not confirmed) with pending investigation.Additional information has been requested and will be provided as it becomes available.Follow-up (27sep2019): new information received from product quality complaint group includes product investigation report.Follow-up (25oct2019): new information received from a contactable consumer included: suspect product details, medical history, reaction data (including additional event 'one "stone" on the top seemed to emit too much heat causing the burn', event outcome updated to recovered, treatment received).Company clinical evaluation comment: based on the information provided, the events of "burns second degree", "intentional device misuse" and "device issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burns second degree", "intentional device misuse", and "device issue" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.
 
Event Description
Burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble [burns second degree], read the usage instructions on thermacare before using the product/ not check the skin under the product while wearing thermacare [intentional device misuse], thermacare lower back & hip for left hip sciatic nerve pain [device use issue].Case narrative: this is a spontaneous report from a contactable consumer (patient).A 69-year-old female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w24913, expiration date 31mar2021, upc number: 305733010037, from (b)(6) 2019 at about 8am to 4pm for 8 hours at 1 wrap for left hip sciatic nerve pain.There were no medical history and no concomitant medications.The patient was currently not under the care of a physician for any medical condition.The patient classified her skin tone as medium, she did not have sensitive skin or abnormal skin conditions.The patient previously used thermacare heatwrap for unknown indication 6-8 months ago for varies time and experienced no adverse effect.The patient had previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) at varies time and experienced no adverse effect.The patient stated she was calling about the recall on thermacare heat wraps.The patient stated that she had a burn from wearing thermacare lower back and hip.The patient stated she just used it this one day on (b)(6) 2019.She used it from about 8am to 4pm.That was when she started to notice the discomfort.Around 4pm after wearing it for 8 hours was when she noticed burning and stinging.The patient stated it was red and blistered with a bubble.The patient stated that she had been using them for years.That's why she was surprised that this happened.She was unsure if she would continue to use the product because she was afraid to now.The patient stated she was trying to fix the soreness and everything, that there was a burn there.The version of thermacare she was using when she experienced the symptoms was back and hip, and the color of the box she purchased was red.There was product remaining.The patient stated it was attached to itself.The patient did not engage in exercise while using the product (for example, running, bicycling).The patient did read the usage instructions on thermacare before she used the product, but she did not check her skin under the product while wearing thermacare.She was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the symptoms was experienced.The patient did not consult a healthcare professional for the symptoms.The patient stated that it was getting better but that it was still there.The patient stated that still had the burn, so she had not recovered completely.The packaging was sealed and intact.The sample of the product was not available to be returned.The action taken in response to the event for thermacare heatwrap was permanently discontinued on (b)(6) 2019.Therapeutic measures were taken as a result of burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble which included put lotion on it and tried to air it out.The outcome of event burn from wearing the thermacare heatwrap/burning and stinging/it was red and blistered with a bubble was recovering.The outcome of the other events was unknown.The reporter provided malfunction as yes.The reporter considered there is a reasonable possibility that ae burn is related to the device.In product investigation report, severity of harm was reported as s3, root cause category (tier 1) as non-assignable (complaint not confirmed) with pending investigation.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burns second degree" and "intentional device misuse" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.Follow-up (27sep2019): new information received from product quality complaint group includes product investigation report.Comment: based on the information provided, the events of "burns second degree" and "intentional device misuse" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event "device use issue" is non-serious.The events are medically assessed as associated with the use of the device.
 
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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 Key9156314
MDR Text Key169221345
Report Number1066015-2019-00234
Device Sequence Number1
Product Code IMD
UDI-Device Identifier00305733010037
UDI-Public305733010037
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2021
Device Lot NumberW24913
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight64
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