MAUDE Adverse Event Report: ANGELINI ROBAX HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no product type, no batch number is available for evaluation without a batch reference number, 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 heat cells damaged/leaking.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 (b)(6) 2022, a spontaneous report from canada was received via telephone regarding a male consumer (age not provided) who used an unspecified robax heat wrap.Medical history and concomitant products were not provided.On an unspecified date the consumer obtained robax heat wraps for an unknown indication.After the consumer received the heat wraps, he observed 2 out of 3 heat wraps were broken.It was further clarified that one of the ends seemed to have not been sown, subsequently the "pucks" were falling out.No additional information was provided.

• Brand Name: ROBAX HEAT WRAP
• 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: 15411298
• MDR Text Key: 306278967
• Report Number: 3007593958-2022-00056
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male