MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Itching Sensation (1943); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "she had a 2nd degree burn at the application site." the cause of the consumer stating she had a 2nd degree burn at the application site 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 when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On 15-mar-2021, a spontaneous report from the united states was received from a consumer regarding a (b)(6)-year old female (ethnicity was not specified) who was using thermacare lower back and hip 8 hour l/xl 2 count (lot number: ar5202, expiration date: april-2022).Medical history included asthma, an allergy to bactrim (trimethoprim/sulfamethoxazole), and a "pinched nerve" in the back which the consumer had surgery scheduled for.The consumer did not use concomitant medications or supplements.On an unspecified date reported as "for a few months", the consumer used thermacare lower back and hip 8-hour l/xl 2 count at an unspecified frequency of application.On (b)(6) 2021, the consumer used the product for her pinched nerve and left the product on for 12 continuous hours.A few minutes after application, the consumer experienced itching.Approximately after 12 hours, when she took it off, she had a 2nd degree burn at the application site.She had discontinued the product since the incident.For treatment, the consumer applied aloe which helped.On (b)(6) 2021, the consumer's burn was noted to be healing and she had not sought consultation with a medical doctor.On (b)(6) 2021, follow up with the reporter revealed that the consumer's symptoms continued to lessen, and she was beginning to scab over.For treatment, she continued to apply aloe to the areas and she denied having to seek medical care.She stated that she did not know that she should not have left the product on that long and admitted that it was her fault for not reading the directions closer.The consumer had retained the product and packaging.No additional information regarding the consumer's events is expected.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11609595
• Report Number: 3007593958-2021-00001
• Device Sequence Number: 14275844
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: AR5202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 77