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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 M47652
Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)
Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)
Event Date 01/02/2016
Event Type  Injury  
Event Description
Burned the back of her skin/red blisters/her skin came off and the blister busted [burns second degree].She applied the product directly to the skin/she wore the product.Overnight or while she slept [intentional device misuse].She experienced pain when she jumped in the shower [pain].Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) , device lot number m47652 , expiration date aug2018 , from (b)(6) 2015 for sciatic nerve problem.Medical history included ongoing postmenopause.The patient's concomitant medications were not reported.The patient started using the product around christmas time, in (b)(6) 2016.She used it once then and once this time, for a total of two times.She applied one heat wrap around midnight on saturday night, (b)(6)2016, and removed the product around 0800 when she woke up on sunday, (b)(6) 2016.She applied the product directly to the skin, as the instructions stated that she could.She wore the product overnight or while she slept.She did not realize that a burn and blister occurred until she removed the product at 0800 on (b)(6) 2016.She has a burn and blister on both sides of her back, straight across.The area felt sticky and she guesses it is because her skin came off and the blister busted.She did not know the degree of burn.On the night of (b)(6) 2016, she experienced pain when she jumped in the shower.States it burned like hell.Her pain improved at the time of the report, but she was concerned she would encounter pain again when she takes another shower.Her blisters were red, but she did not seek any medical intervention at the time of the report.She applied neosporin and applied a bandage to each side of her back.States it is ok at this time, clarifies the area was about the same.She did not know if there would be any permanent damage as a result.She was uncertain if she would experience an infection.She could have a scar as a result.She permanently discontinued the product and did not recommend the product to any one.The patient considered it was possible that it is related to the device.The patient was not under the care of a physician for any medical condition currently; patient had no conditions listed below: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy; skin tone was fair; no sensitive skin; no any abnormal skin conditions; the same problem/symptom was not occurred during previous use.Patient did not use other heat products for pain relief previously; patient was not wearing several layers of clothing over the thermacare product, she only wore underwear and pajamas.Did not wear a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride) ; did not engage in exercise while using the product; did not check skin under the product while wearing thermacare because she was sleeping.She was unaware of her injuries during the night.Read the usage instructions on thermacare before used the product; no medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced; also reported it was hard to read the information on the box regarding the manufacturer.She had to get a magnifying glass.The pfizer information was very small.The directions were clear.The product was sealed appropriately.At the time of report, event experienced burned the back of her skin/red blisters/her skin came off and the blister busted was not recovered , experienced pain when she jumped in the shower was recovering , and event outcome for she applied the product directly to the skin/she wore the product overnight or while she slept 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 events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.
 
Event Description
Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) , device lot number m47652 , expiration date aug2018 , from (b)(6) 2015 for sciatic nerve problem.Medical history included ongoing postmenopause.The patient's concomitant medications were not reported.The patient started using the product around christmas time, in (b)(6) 2015.She used it once then and once this time, for a total of two times.She applied one heat wrap around midnight on saturday night, (b)(6) 2016, and removed the product around 0800 when she woke up on sunday, (b)(6) 2016.She applied the product directly to the skin, as the instructions stated that she could.She wore the product overnight or while she slept.She did not realize that a burn and blister occurred until she removed the product at 0800 on (b)(6) 2016.She has a burn and blister on both sides of her back, straight across.The area felt sticky and she guesses it is because her skin came off and the blister busted.She did not know the degree of burn.On the night of (b)(6) 2016, she experienced pain when she jumped in the shower.States it burned like hell.Her pain improved at the time of the report, but she was concerned she would encounter pain again when she takes another shower.Her blisters were red, but she did not seek any medical intervention at the time of the report.She applied neosporin and applied a bandage to each side of her back.States it is ok at this time, clarifies the area was about the same.She did not know if there would be any permanent damage as a result.She was uncertain if she would experience an infection.She could have a scar as a result.She permanently discontinued the product on (b)(6) 2016 and did not recommend the product to anyone.The patient considered it was possible that it is related to the device.The patient was not under the care of a physician for any medical condition currently; patient had no conditions listed below: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy; skin tone was fair; no sensitive skin; no any abnormal skin conditions; the same problem/symptom was not occurred during previous use.Patient did not use other heat products for pain relief previously; patient was not wearing several layers of clothing over the thermacare product, she only wore underwear and pajamas.Did not wear a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride) ; did not engage in exercise while using the product; did not check skin under the product while wearing thermacare because she was sleeping.She was unaware of her injuries during the night.Read the usage instructions on thermacare before used the product; no medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced; also reported it was hard to read the information on the box regarding the manufacturer.She had to get a magnifying glass.The pfizer information was very small.The directions were clear.The product was sealed appropriately.At the time of report, event experienced burned the back of her skin/red blisters/her skin came off and the blister busted was not recovered , experienced pain when she jumped in the shower was recovering , and event outcome for she applied the product directly to the skin/she wore the product overnight or while she slept was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (04jan2016): new information received in response to a query included the start and stop dates of the suspect product were confirmed to be (b)(6) 2015 and (b)(6) 2016 respectively.Company clinical evaluation comment based on the information provided, the events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets follow up 10-day eu and 30-day fda reportability.
 
Manufacturer Narrative
The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.
 
Event Description
Case description: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian female patient (not pregnant) started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number: m47652, expiration date: aug2018) from (b)(6) 2015 for sciatic nerve problem.Medical history included ongoing postmenopause.The patient's concomitant medications were not reported.The patient started using the product around christmas time, in (b)(6) 2015.She used it once then and once this time, for a total of two times.The patient applied one heat wrap around midnight on (b)(6) night, (b)(6) 2016, and removed the product around 0800 when she woke up on (b)(6) 2016.She applied the product directly to the skin, as the instructions stated that she could.The patient wore the product overnight or while she slept.She did not realize that a burn and blister occurred until she removed the product at 0800 on (b)(6) 2016.The patient has a burn and blister on both sides of her back, straight across.The area felt sticky and she guesses it is because her skin came off and the blister busted.She did not know the degree of burn.On the night of (b)(6) 2016, she experienced pain when she jumped in the shower.She stated it burned like hell.Her pain improved at the time of the report, but she was concerned she would encounter pain again when she takes another shower.Her blisters were red, but she did not seek any medical intervention at the time of the report.She applied neosporin and applied a bandage to each side of her back.States it is ok at this time, clarifies the area was about the same.She did not know if there would be any permanent damage as a result.She was uncertain if she would experience an infection.The patient could have a scar as a result.She permanently discontinued the product on (b)(6) 2016 and did not recommend the product to anyone.The patient considered it was possible that it is related to the device.She was not under the care of a physician for any medical conditions currently.She had none of the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation or neuropathy.The patient's skin tone was assessed as fair.She denied having sensitive skin or any abnormal skin conditions.The same problem/symptom did not occur during previous use.The patient did not use other heat products for pain relief previously.She was not wearing several layers of clothing over the thermacare product, she only wore underwear and pajamas.The patient did not wear a snug waistband/belt or similar or otherwise applied pressure over the area (for example, prolonged car ride).She did not engage in exercise while using the product.The patient did not check her skin under the product while wearing thermacare because she was sleeping.She was unaware of her injuries during the night.The patient read the usage instructions on thermacare before using the product.She was not taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.Also, she reported it was hard to read the information on the box regarding the manufacturer.She had to get a magnifying glass as the pfizer information was very small.The directions were clear.The product was sealed appropriately.At the time of the report, clinical outcome of the events experienced burned the back of her skin/red blisters/her skin came off and the blister busted was not recovered.Clinical outcome of the event pain when she jumped in the shower was recovering.Clinical outcome of the event she applied the product directly to the skin/she wore the product overnight or while she slept was unknown.New information received from product quality complaint (pqc) group includes investigation results.The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information received in response to a query included the start and stop dates of the suspect product were confirmed to be (b)(6) 2015 and (b)(6) 2016 respectively.Follow-up (04mar2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected company clinical evaluation comment based on the information provided, the events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets final10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree and intentional 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 event pain is assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.
 
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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
b green
235 e42nd street
new york, NY 10017
2127334552
MDR Report Key5386238
MDR Text Key36681038
Report Number1066015-2016-00001
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 01/04/2016
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
Device Expiration Date08/01/2018
Device Lot NumberM47652
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/04/2016
Initial Date FDA Received01/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/26/2016
03/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight50
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