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

Lot Number L12789

Device Problem Temperature Problem (3022)

Patient Problems Fever (1858); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 12/14/2015

Event Type  Injury  

Event Description

Second degree burns on her back on the lower left side probably below the kidney [burns second degree].Heat wrap was getting too hot [product quality issue].There was drainage from the burns but not pus it was not green [wound drainage].Back pain got worse [back pain].Fever [pyrexia].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of her mother.This (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare heatwrap) (device lot number: l1278906/11, expiration date: may2018) from an unspecified date for back ache.Medical history included congestive heart failure from an unknown date and unknown if ongoing.Concomitant medication included warfarin sodium (coumadin) from an unspecified date for an unspecified indication.On (b)(6) 2015, the reporter stated her mother used the heatwrap for 2 to 3 hours and her back pain got worse.Subsequently, she removed the heatwrap and realized her back was wet and wondered what that was.The reporter's sister went over to look at the patient's back and took a picture of her mother's back that has open wounds.The reporter stated the burns were open so she assumed they were second degree burns on her back "on the lower left side probably below the kidney".The patient felt the heatwrap was getting too hot so she removed it, but continued to feel burning on her skin.The patient noted clear drainage from the burns but not pus, it was not green.The reporter stated her mother was a nurse, so she was watching it very carefully.She stated "all that she has done is put on a clean dressing".The reporter stated her mother had a fever and was going to the doctor on (b)(6) 2015.The reporter stated her mother threw away the heatwrap in the dustbin.The patient had not undergone any lab work related to the burns.The patient's skin tone was assessed as very light.She did not use any creams, rubs or gels under the wrap.The patient had not used thermacare heatwraps in the past.There were no defects in the wrap like cuts, tears, leaks or holes.She did not change or modify the wrap in any way.The reporter stated her mother used the heatwrap over the correct part of the body and did not apply any pressure over the wrap.Her mother did not wear more than 2 layers of clothing over the wrap, she just wore a tee-shirt.The patient did not exercise while using the wrap as her back was in too much pain.She did not use the heatwrap over night or while sleeping.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included a administering a clean dressing.Clinical outcome of the event was not resolved.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, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events burns second degree, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as associated with the device.This case meets initial 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 review of batch device history records, in process quality check results 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 in process specifications.Consumer alleges a wrap too hot.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.The cause of the alleged too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The alleged defective sample has not been received at the site for evaluation.

Event Description

Case description: this is a spontaneous report from a contactable consumer reporting on behalf of her mother.This (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip).(device lot number: l12789, expiration date: may2018) from an unspecified date for back ache.Medical history included congestive heart failure from an unknown date and unknown if ongoing.Concomitant medication included warfarin sodium (coumadin) from an unspecified date for an unspecified indication.On (b)(6) 2015, the reporter stated her mother used the heatwrap for 2 to 3 hours and her back pain got worse.Subsequently, she removed the heatwrap and realized her back was wet and wondered what that was.The reporter's sister went over to look at the patient's back and took a picture of her mother's back that has open wounds.The reporter stated the burns were open so she assumed they were second degree burns on her back "on the lower left side probably below the kidney".The patient felt the heatwrap was getting too hot so she removed it, but continued to feel burning on her skin.The patient noted clear drainage from the burns but not pus, it was not green.The reporter stated her mother was a nurse, so she was watching it very carefully.She stated "all that she has done is put on a clean dressing".The reporter stated her mother had a fever and was going to the doctor on (b)(6) 2015.The reporter stated her mother threw away the heatwrap in the dustbin.The patient had not undergone any lab work related to the burns.The patient's skin tone was assessed as very light.She did not use any creams, rubs or gels under the wrap.The patient had not used thermacare heatwraps in the past.There were no defects in the wrap like cuts, tears, leaks or holes.She did not change or modify the wrap in any way.The reporter stated her mother used the heatwrap over the correct part of the body and did not apply any pressure over the wrap.Her mother did not wear more than 2 layers of clothing over the wrap, she just wore a tee-shirt.The patient did not exercise while using the wrap as her back was in too much pain.She did not use the heatwrap over night or while sleeping.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included a administering a clean dressing.Clinical outcome of the event was not resolved.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 review of batch device history records, in process quality check results 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 in process specifications.Consumer alleges a wrap too hot.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.The cause of the alleged too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The alleged defective sample has not been received at the site for evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (04feb2016): new information received from product quality complaints (pqc) group included: updated.Suspect product and provided product quality investigation results.Company clinical evaluation comment based on the information provided, the events burns second degree, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as associated with the device.This case meets follow up10-day eu and 30-day fda reportability.Case comment: company clinical evaluation comment based on the information provided, the events burns second degree, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as associated with the device.This case meets follow up10-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 review of batch device history records, in process quality check results 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 in process specifications.Consumer alleges a wrap too hot.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.The cause of the alleged too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The alleged defective sample has not been received at the site for evaluation.

Event Description

Case description: this is a spontaneous report from a contactable consumer reporting on behalf of her mother.This (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: l12789, expiration date: may2018) from an unspecified date for back ache.Medical history included congestive heart failure from an unknown date and unknown if ongoing.Concomitant medication included warfarin sodium (coumadin) from an unspecified date for an unspecified indication.On (b)(6) 2015, the reporter stated her mother used the heatwrap for 2 to 3 hours and her back pain got worse.Subsequently, she removed the heatwrap and realized her back was wet and wondered what that was.The reporter's sister went over to look at the patient's back and took a picture of her mother's back that has open wounds.The reporter stated the burns were open so she assumed they were second degree burns on her back "on the lower left side probably below the kidney".The patient felt the heatwrap was getting too hot so she removed it, but continued to feel burning on her skin.The patient noted clear drainage from the burns but not pus, it was not green.The reporter stated her mother was a nurse, so she was watching it very carefully.She stated "all that she has done is put on a clean dressing".The reporter stated her mother had a fever and was going to the doctor on (b)(6) 2015.The reporter stated her mother threw away the heatwrap in the dustbin.The patient had not undergone any lab work related to the burns.The patient's skin tone was assessed as very light.She did not use any creams, rubs or gels under the wrap.The patient had not used thermacare heatwraps in the past.There were no defects in the wrap like cuts, tears, leaks or holes.She did not change or modify the wrap in any way.The reporter stated her mother used the heatwrap over the correct part of the body and did not apply any pressure over the wrap.Her mother did not wear more than 2 layers of clothing over the wrap, she just wore a tee-shirt.The patient did not exercise while using the wrap as her back was in too much pain.She did not use the heatwrap over night or while sleeping.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included a administering a clean dressing.Clinical outcome of the event was not resolved.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 review of batch device history records, in process quality check results 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 in process specifications.Consumer alleges a wrap too hot.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.The cause of the alleged too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The alleged defective sample has not been received at the site for evaluation.Additional information has been requested and will be provided as it becomes available.Follow-up (04feb2016): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.Follow-up (25feb2016): this follow up is being submitted to notify that follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment based on the information provided, the events burns second degree, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as 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 burns second degree, wound drainage, and product quality issue (product complaint considered associated) 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 back pain and pyrexia are assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.

• 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 Key: 5363053
• MDR Text Key: 35760462
• Report Number: 1066015-2015-00164
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2018
• Device Lot Number: L12789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 58