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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
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Itching Sensation (1943); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331); Sweating (2444); Partial thickness (Second Degree) Burn (2694)
Event Date 03/03/2015
Event Type  Injury  
Event Description
Ulcerous waterfilled burn blister on the lower back [burns; second degree].Sweating of lower back [hyperhidrosis].Lower back itching [pruritus], pain of the blister site (lower back) [pain].Case description: this is a spontaneous report from a non-clinical study program brand websites for division consumer healthcare germany received from a contractable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) in (b)(6) 2015 for an unspecified indication.The patient wore many layers of clothes as it was cold and she wanted to spend 7-8 hrs outside.The patient medical history was not reported.The patient's concomitant medications were not reported.After half of the day, the patient experienced lower back itching & sweating, thereafter, pain of the blister site in (b)(6) 2015.In the evening, after she was back to home, she saw ulcerous water filled burn blister on the lower back.The treatment was very difficult even w/expensive special products from pharmacy, the healing process lasted 2 weeks.After 2 weeks, the blisters disappeared & then the skin was regenerated.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events were recovered on an unknown date in 2015.Additional information has been requested and will be provided as it becomes available.Based on the information provided, the event burn blister as described in this case, is considered a serious bodily injury, requiring medical intervention to prevent permanent damage or impairment of body structure, & the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Based on the info provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment ob body structure, and the event is assessed as associated w/the use of the device.This case meets initial 10-day eu & 30 day fda reportability.
 
Event Description
Ulcerous waterfilled burn blister on the lower back [burns second degree].Wore many layers of clothes as it was cold and she wanted to spend 7-8 hours outside [device misuse].Sweating of lower back [hyperhidrosis].Lower back itching [pruritus].Pain of the blister site (lower back) [pain].Only scars remained [scar].Case description: this is a spontaneous report from a non-clinical-study program, brand websites for division consumer healthcare (b)(6) received from a contactable consumer.A (b)(6) year-old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) one time on (b)(6) 2015 for 3 hours for back problems.The patient's medical history included cardiac disorder from an unspecified date and unknown if ongoing.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2015 for approximately 3 hours for an unspecified indication and was well tolerated.On (b)(6) 2015, the patient attached the product directly to her body and wore many layers of clothes over the heatwrap as it was cold and she wanted to spend 7-8 hours outside.After approximately 1 hour, she noticed slight stitches beginning around 10 am.The patient stated they were "innoxious at the beginning and got worse and worse with every minute".She reported her lower back was itching and sweating; thereafter, pain of the blister site.In the evening after she returned home, she indicated she could hardly walk because of the pain.Upon removing the heatwrap, she noted ulcerous water-filled burn blisters on her lower back.Treatment was reported as very difficult, even with expensive burn cream and bandages from the pharmacy the healing process lasted 2 weeks.After 2 weeks the blisters disappeared and the skin was regenerated.The patient indicated "only scars" remained.The patient's skin tone was assessed as medium light.She denied having sensitive skin.No other "warmth inducing" products were used in the past.The patient had read the instruction leaflet prior to product usage.Action taken in response to the event for thermacare heatwrap was unknown.Therapeutic measures taken included unspecified burn cream and bandages provided by the pharmacist.No hospitalization was required as a result of the events.Clinical outcome of the event burn blister was resolved with sequelae on an unspecified date in 2015.Clinical outcome of the events pain, hyperhidrosis and pruritus was resolved on an unspecified date in 2015.Clinical outcome of the remaining events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2015): new information received from a contactable consumer includes: patient details, medical history, past product history, suspect product start date, suspect product indication, reaction data (additional events of device misuse and scars), no hospitalization required and therapeutic measures taken.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events burn blister and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events scars, sweating, itching, and pain are considered associated with the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burn blister and device misuse as described in this case are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.The other events scars, sweating, itching, and pain are considered associated with the device.This case meets final 10-day eu and 30-day fda reportability.
 
Manufacturer Narrative
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, 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.Summary of investigation: 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.Reasonably suggest device malfunction: no; severity of harm: n/a site sample status: not received.
 
Event Description
Event verbatim [preferred term], uclerous water filled burn blister on the lower back [burns second degree], wore many layers of clothes as it was cold and she wanted to spend 7-8 hours outside [intentional device misuse], sweating of lower back [hyperhidrosis], lower back itching [pruritus], pain of the blister site (lower back) [pain], only scars remained [scar], , narrative: this is a spontaneous report from a non-clinical-study program, brand websites for division consumer healthcare germany received from a contactable consumer.A 20-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) one time on (b)(6) 2015 for 3 hours for back problems.The patient's medical history included cardiac disorder from an unspecified date and unknown if ongoing.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2015 for approximately 3 hours for an unspecified indication and was well tolerated.On (b)(6) 2015, the patient attached the product directly to her body and wore many layers of clothes over the heatwrap as it was cold and she wanted to spend 7-8 hours outside.After approximately 1 hour, she noticed slight stitches beginning around 10 am.The patient stated they were "innoxious at the beginning and got worse and worse with every minute".She reported her lower back was itching and sweating; thereafter, pain of the blister site.In the evening after she returned home, she indicated she could hardly walk because of the pain.Upon removing the heatwrap, she noted ulcerous water-filled burn blisters on her lower back.Treatment was reported as very difficult, even with expensive burn cream and bandages from the pharmacy the healing process lasted 2 weeks.After 2 weeks the blisters disappeared and the skin was regenerated.The patient indicated "only scars" remained.The patient's skin tone was assessed as medium light.She denied having sensitive skin.No other "warmth inducing" products were used in the past.The patient had read the instruction leaflet prior to product usage.Action taken in response to the event for thermacare heatwrap was unknown.Therapeutic measures taken included unspecified burn cream and bandages provided by the pharmacist.No hospitalization was required as a result of the events.Clinical outcome of the event burn blister was resolved with sequelae on an unspecified date in 2015.Clinical outcome of the events pain, hyperhidrosis and pruritus was resolved on an unspecified date in 2015.Clinical outcome of the remaining events was unknown.Per the product quality group: 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, 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.Summary of investigation: 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.Reasonably suggest device malfunction: no; severity of harm: n/a; site sample status: not received follow-up (25aug2015): new information received from a contactable consumer includes: patient details, medical history, past product history, suspect product start date, suspect product indication, reaction data (additional events of device misuse and scars), no hospitalization required and therapeutic measures taken.Follow-up (04jun2020): new information received from product quality group includes: investigation results.Follow-up attempts are completed.No further information is expected.
 
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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 Key4943473
MDR Text Key24648188
Report Number1066015-2015-00090
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,consumer,foreign
Type of Report Initial,Followup
Report Date 07/15/2015
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 07/15/2015
Initial Date FDA Received07/23/2015
Supplement Dates Manufacturer Received08/25/2015
Supplement Dates FDA Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
Patient Weight52
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