MAUDE Adverse Event Report: ANGELINI THERMACARE MUSCLE/JOINT 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Model Number	ThermaCare HeatWraps - Muscle & Joint
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause cannot be identified.There is limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass wrap/patch pad never worked/unusable.Due to the potential for device leakage, this complaint was assessed as reportable to the fda because consumer states "the little pockets look and feel like they are filled so full they are about to burst open.").No adverse event was reported, no product cell pack leakage was reported.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.
Event or Problem Description
On 16-mar-2022, a spontaneous report from the united states was received from a consumer via email regarding a female consumer (age not reported) who was using thermacare menstrual 8hr 3ct.Medical history and concomitant products were not provided.On an unspecified date, the consumer noted that all three heat wraps in the box were not working.The consumer stated, "the little pockets look and feel like they are filled so full they are about to burst open and are hard as a rock." a follow up email was sent to the consumer on 18-mar-2022.No additional information available.

• Brand Name: THERMACARE MUSCLE/JOINT 8HR 3CT
• 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: 13982822
• Report Number: 3007593958-2022-00019
• Device Sequence Number: 12154626
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• 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): 04/01/2022

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 - Muscle & Joint
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/01/2022
• 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: Female