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

Model Number	ThermaCare HeatWraps - Lower Back & Hip
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
On 27-apr-2022, a spontaneous report was received from the united states via email from a consumer regarding a male consumer (age not provided) who used thermacare lower back and hip l/xl heat wraps.Medical history included arthritis in the knees and prior use of thermacare lower back and hip heat wraps without issues.Concomitant products were not provided.On an unspecified date, the consumer purchased a package of thermacare lower back and hip heat wraps.On an unspecified date, after the consumer opened the package, he discovered that 6 to 7 wraps were damaged.It appeared that the wraps were cut incorrectly which exposed the heating material to the air.No additional information was provided.
Additional Manufacturer Narrative
The root cause cannot be identified.There was limited device-specific information provided, the batch number was not available.Without a batch reference number, or a returned sample for evaluation a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass heat cell damaged/leaking.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is a product quality complaint for a heat cell damaged/leaking; risk calculation would be determined as major-skin burn.

• Brand Name: THERMACARE LOWER BACK & HIP L/XL 8HR
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 14434962
• Report Number: 3007593958-2022-00033
• Device Sequence Number: 5634787
• Product Code: IMD
• UDI-Device Identifier: 00305733010389
• UDI-Public: 00305733010389
• Combination Product (Y/N): N
• 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): 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male