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

Model Number ThermaCare HeatWraps - Muscle & Joint

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 288852469
• Report Number: 3007593958-2022-00019
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013038
• UDI-Public: 00305733013038
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Muscle & Joint
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female