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

Lot Number T38952 0/24

Device Problems Overheating of Device (1437); Use of Device Problem (1670); Torn Material (3024)

Patient Problems Pain (1994); Impaired Healing (2378); Burn, Thermal (2530)

Event Date 11/12/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] pain and sufferings/burnt 2 holes on the each side of my lower back/the burning on my lower back/severe burns on back/open wounds [thermal burn] , the holes on my back that taking a long time to heal due to the severity of the burns/isn't even healed yet [impaired healing] , she had to tie it on [device use error] , pc- the velcro thing came right off and was ripped.Another wrap was twisted.[product quality issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) -year-old female patient of an ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number t38952 0/24, expiration date jun2020) from an unspecified date for an unspecified indication.The patient medical history included dermatitis, sensitive skin due to allergies.The patient's concomitant medications were not reported.The velcro thing came right off and it ripped on one of the wraps.There were 3 wraps in the box.The part that went on the back with another wrap was twisted.The patient stated that she had to tie the wrap on (b)(6) 2017.The patient reported that "i will never use this product again.It has cost me more pain and suffering.My lawyer said for me to suggest that (b)(4) cost me a check will seek for more because of the holes in my back that's taking a long time to heal due to the severity of the burns your product caused.I had to pay for over the counter medications to stop the burning on my lower back, now have spread dermatitis due to this making holes in my back when i get any cuts on my barely i get dermatitis and it cost a lot to take care of it.I have to use organic and non-steroidal medicines and they all came from a natural product company.A severe burns on back and meds over the counter has caused.If you cannot comply my lawyer said that he can saw (b)(4) company for more but i'm only asking to pay for medicines and what else has been mentioned several times.Please honor this, i don't want to go to court.Because of your product.My back is worse now that it even was.I'm in terrible pain.The seeping from the open wounds your product has caused me to have and isn't even healed yet." the sample of the product was not available to be returned.The action taken in response to the events was unknown.The outcomes of these events were not recovered.Follow up ((b)(6) 017): new information received from a contactable consumer reported in response to non-hcp letter included that: patient's age, events details, new events information, case upgraded to serious.Company clinical evaluation comment: based on the information provided, the events of thermal burn, impaired healing, device use error, and product quality issue are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.All events are assessed as associated with the use of the device., comment: based on the information provided, the events of thermal burn, impaired healing, device use error, and product quality issue are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.All events are assessed as associated with the use of the device.

• 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
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 7120594
• MDR Text Key: 94976712
• Report Number: 1066015-2017-00179
• 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: Other
• Type of Report: Initial
• Report Date: 11/21/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Lot Number: T38952 0/24
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR