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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Rheumatoid Arthritis (1724); Neuropathy (1983); Pain (1994); Vascular System (Circulation), Impaired (2572); Partial thickness (Second Degree) Burn (2694)

Event Date 01/18/2020

Event Type  Injury  

Event Description

I used one thermacare patch and it burned my back/i have big blisters on my back and i didn't even have it for the recommended time; i had it on me for 4 or 5 hours [burns second degree], did not check skin under the product while wearing thermacare [device use error].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) old-consumer of unknown gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration on (b)(6) 2020 at one time for back pain.Medical history and concomitant medication were none.Consumer stated used one of the patches, the thermacare patch and it burned the back on (b)(6) 2020.Consumer had big blisters on the back and didn't even have it for the recommended time.Consumer had it on about 4 hours and it burned the back.Consumer was not currently under the care of a physician for any medical condition.Consumer had no conditions diabetes, poor circulation, heart disease, and difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.Consumer classified the skin tone as medium.Consumer did not have sensitive skin or abnormal skin conditions.Consumer purchased red box.The product was remaining.Number of days in a row that thermacare was used was 1 day.Consumer had not previously used thermacare or other heat products for pain relief.While wearing thermacare, consumer was just wearing a t-shirt.Consumer was lying on bed but wasn't asleep.Consumer did not engage in exercise while using the product.Consumer did not check skin under the product while wearing thermacare.Consumer read the usage instructions on thermacare before used the product.Consumer want the company to fix the problem so that it did not burn people and consumer had never used anything like before.This was the first time and it burned the skin and consumer had blister on back and that should not happen.Consumer did not consult a healthcare professional for the problems.There was blister on back.They were going to tell consumer to use a burn cream.Consumer didn't need to go to the doctor and get the bill for hundreds of dollars to be told to use burn cream.Consumer did not go to the hospital for so.It was just a burn, consumer didn't need to go the doctor.Consumer knew what to do.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2020.The outcome of the events 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 event burn blisters as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use error is considered non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event burn blisters as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event device use error is considered non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] i used one thermacare patch and it burned my back/i have big blisters on my back and i didn't even have it for the recommended time; i had it on me for 4 or 5 hours [burns second degree], did not check skin under the product while wearing thermacare/read the usage instructions on thermacare before used the product [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer.This 40-year-old-consumer of unknown gender started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration on (b)(6) 2020 at one time for back pain.Medical history and concomitant medication were none.Consumer stated used one of the patches, the thermacare patch and it burned the back on (b)(6) 2020.Consumer had big blisters on the back and didn't even have it for the recommended time.Consumer had it on about 4 hours and it burned the back.Consumer was not currently under the care of a physician for any medical condition.Consumer had no conditions diabetes, poor circulation, heart disease, and difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.Consumer classified the skin tone as medium.Consumer did not have sensitive skin or abnormal skin conditions.Consumer purchased red box.The product was remaining.Number of days in a row that thermacare was used was 1 day.Consumer had not previously used thermacare or other heat products for pain relief.While wearing thermacare, consumer was just wearing a t-shirt.Consumer was lying on bed but wasn't asleep.Consumer did not engage in exercise while using the product.Consumer did not check skin under the product while wearing thermacare.Consumer read the usage instructions on thermacare before used the product.Consumer want the company to fix the problem so that it did not burn people and consumer had never used anything like before.This was the first time and it burned the skin and consumer had blister on back and that should not happen.Consumer did not consult a healthcare professional for the problems.There was blister on back.They were going to tell consumer to use a burn cream.Consumer didn't need to go to the doctor and get the bill for hundreds of dollars to be told to use burn cream.Consumer did not go to the hospital for so.It was just a burn, consumer didn't need to go the doctor.Consumer knew what to do.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2020.The outcome of the events was unknown.According to the product quality complaint group on (b)(6) 2020: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 and/or return sample 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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status is not received.Severity of harm is s3.Follow-up (10mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the event burn blisters as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device misuse is considered non-serious.The events are medically assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour product.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 and/or return sample 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/serious/unknown.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status is not received.Severity of harm is s3.

• 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: 9682315
• MDR Text Key: 185781618
• Report Number: 1066015-2020-00030
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 79