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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, no batch number or return sample available for evaluation.Without a batch reference number, 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 cells 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.

Event Description

On 10-feb-2022, a spontaneous report from the united states was received from a consumer regarding a (b)(6) female consumer who used thermacare lower back and hip 8hr l/xl heat wrap.Medical history included asthma, diabetes, "nearly blind", and myelodysplastic syndrome.The reporter declined to provide concomitant products.On an unspecified date, approximately since 2017, the consumer has applied approximately 4 thermacare lower back and hip 8hr l/xl heat wraps (lot numbers not provided; one expiration date was known 15-jan-2022) per week without issues.On unspecified dates, reported as "recent", the consumer experienced one heat wrap did not heat up.She also experienced one of the heat wraps broke.It was further clarified that it leaked.The consumer discarded the products and was unable to provide any further specific device information.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• 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: 13716182
• MDR Text Key: 286928467
• Report Number: 3007593958-2022-00012
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 00305733010037
• 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: 03/04/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/09/2022
• 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 Age: 68 YR
• Patient Sex: Female