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

Lot Number T48936

Device Problem Burst Container or Vessel (1074)

Patient Problems Purulent Discharge (1812); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 04/17/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] second degree burns/painful/two big holes/felt these big bumps on the top of her buttocks.Turned out to be big blisters when they popped/they scooped out my skin/still having pus come out [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) caucasian (reported as other white) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t48936, expiry date: jun2020, ndc number: (b)(4), upc number: (b)(4), from (b)(6) 2018 for an unspecified indication.There were no medical history and no concomitant medications.The patient previously used heating pad for pain relief for chronic lower back pain, maybe twice a week two times a week.The patient used to wear lidocaine patches that were prescribed by her doctor but her insurance wouldn't cover them anymore.The product thermacare lower back & hip was purchased over the counter.This was the first time she used the product.The patient got second degree burns from the product on (b)(6) 2018.The patient used it approximately on (b)(6) 2018.She put it on, she didn't even have it on for 8 hours, she had it on for 6 hours and she didn't know it was getting burn until the next day ((b)(6) 2018) she was taking her underwear down and she felt these big bumps on the top of her buttocks and it turned out to be big blisters when they popped and what a mess she was going through.It was so painful, she never knew that a second degree burn could be that painful and it was still having pus come out and things like that, and now she had like two big holes and one smaller one which they were still open.The patient mentioned she didn't use it wrong at all, she didn't put it directly on skin there was a barrier, she followed instructions and like she said she didn't even have it on for 8 hours either.The patient had to go to the doctor it was very painful and round up going to the doctor on (b)(6).She still had them.She has to go to the doctor again, they were saying it was a second degree burns.The patient received antibiotics as treatment and then she had the silvadene cream for burns.The patient mentioned, "i don't know if you do understand it if somebody took a spoon and scooped out because the burns are that bad they scooped out my skin." she was in a lot of pain it was horrible she couldn't sit for a week on an unspecified date in 2018.The patient was currently under the care of a physician for any medical condition.She denied having the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.The patient classified her skin tone as medium to dark; she did not have sensitive skin or any abnormal skin conditions.The color of the box purchased was red box and there was no product remaining.There was no lab work.The patient stated she just called the fda actually too.The patient mentioned, "i don't know what to do.I want either i am going to call malpractice lawyer or put it on my (b)(4).Page on social media you know don't use this along with my pictures i have tones of pictures i think should be compensated for my pain and suffering period." the action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of event second degree burns/painful/two big holes/felt these big bumps on the top of her buttocks/ turned out to be big blisters when they popped/they scooped out my skin/still having pus come out was not recovered.The outcome of the other event was unknown.The device was available for evaluation.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" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burns second degree" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-28881, effective date: 08jun2017.Consumer reports "second degree burns from one of your products".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] second degree burns/painful/two big holes/felt these big bumps on the top of her buttocks/ turned out to be big blisters when they popped/they scooped out my skin/still having pus come out [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 54-year-old caucasian (reported as other white) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t48936, expiry date: jun2020, ndc number: 0573301003, upc number: 305733010037, from 16apr2018 for an unspecified indication.There were no medical history and no concomitant medications.The patient previously used heating pad for pain relief for chronic lower back pain, maybe twice a week two times a week.The patient used to wear lidocaine patches that were prescribed by her doctor but her insurance wouldn't cover them anymore.The product thermacare lower back & hip was purchased over the counter.This was the first time she used the product.The patient got second degree burns from the product on (b)(6) 2018.The patient used it approximately on (b)(6) 2018.She put it on, she didn't even have it on for 8 hours, she had it on for 6 hours and she didn't know it was getting burn until the next day (b)(6) 2018 she was taking her underwear down and she felt these big bumps on the top of her buttocks and it turned out to be big blisters when they popped and what a mess she was going through.It was so painful, she never knew that a second degree burn could be that painful and it was still having pus come out and things like that, and now she had like two big holes and one smaller one which they were still open.The patient mentioned she didn't use it wrong at all, she didn't put it directly on skin there was a barrier, she followed instructions and like she said she didn't even have it on for 8 hours either.The patient had to go to the doctor it was very painful and round up going to the doctor on 18th.She still had them.She has to go to the doctor again, they were saying it was a second degree burns.The patient received antibiotics as treatment and then she had the silvadene cream for burns.The patient mentioned, "i don't know if you do understand it if somebody took a spoon and scooped out because the burns are that bad they scooped out my skin." she was in a lot of pain it was horrible she couldn't sit for a week on an unspecified date in 2018.The patient was currently under the care of a physician for any medical condition.She denied having the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.The patient classified her skin tone as medium to dark; she did not have sensitive skin or any abnormal skin conditions.The color of the box purchased was red box and there was no product remaining.There was no lab work.The patient stated she just called the fda actually too.The patient mentioned, "i don't know what to do.I want either i am going to call malpractice lawyer or put it on my facebook page on social media you know don't use this along with my pictures i have tones of pictures i think should be compensated for my pain and suffering period." the action taken in response to the events for thermacare heatwrap was permanently withdrawn on 16apr2018.The outcome of event second degree burns/painful/two big holes/felt these big bumps on the top of her buttocks/ turned out to be big blisters when they popped/they scooped out my skin/still having pus come out was not recovered.The device was available for evaluation.Investigation results according to product quality complaints group included: investigation summary: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria per spec-28881, effective date: 08jun2017.Consumer reports "second degree burns from one of your products".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Additional information has been requested and will be provided as it becomes available.Follow-up (22may2018): new information received from a product quality complaints group included: investigation results.Company clinical evaluation comment based on the information provided, the events of "burns second degree" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burns second degree" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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 Key: 7486500
• MDR Text Key: 107450072
• Report Number: 1066015-2018-00061
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

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 Date: 06/01/2020
• Device Lot Number: T48936
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 68