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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/01/2021
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 " itching and burning sensation at application site".The cause of the consumer stating she had "itching and burning sensation at 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 blisters or other skin irritations.This is an adverse event for an itching and burning sensation at application site; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
Event or Problem Description
On (b)(6) 2021, a spontaneous report from the united states was received via telephone from a consumer regarding a female (age and ethnicity were not specified) who was using a thermacare lower back and hip 8hr l/xl heat wrap.Medical history included prior use of thermacare "off and on" without issue.The consumer had allergies to sulfonamides, chlorthalidone, and unspecified eye drops.On an unspecified date in (b)(6) 2021, the consumer topically applied the thermacare lower back and hip 8hr l/xl (lot number: ek9242, expiration date: 31-oct-2023) heat wrap to her right hip for an unspecified indication.After the consumer applied the heat wrap, she left the thermacare lower back and hip on for "most of the day".When she removed the heat wrap, she did not notice anything.One or two days later, she developed blisters at the application site.She accidently broke one of the blisters while changing clothes and it became "really painful".The skin was open, and she was concerned about the possibility of infection.Subsequently, the consumer visited an urgent care.The doctor did a visual analysis and told her she had second degree burns at the application site.She was prescribed a topical and oral antibiotic.As of (b)(6) 2021, her symptoms had resolved.No additional information was provided.

• 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: 12520116
• Report Number: 3007593958-2021-00036
• Device Sequence Number: 4080166
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/23/2021

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: 10/31/2023
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: EK9242
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/23/2021
• 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