MAUDE Adverse Event Report: ANGELINI THERMACARE JOINT THERAPY 8HR 4CT; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Flexible

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/18/2021

Event Type  malfunction  

Event Description

On 20-aug-2021, a spontaneous report from the united states was received via telephone from a (b)(6) female consumer regarding the thermacare joint therapy 8hr 4ct.Medical history and information regarding usage of concomitant products were not provided.On about (b)(6) 2021, the consumer opened two boxes of thermacare joint therapy 8hr 4ct (expiration dates of 11/2023 and 04/2023).When opening the products, she discovered that approximately four of them did not heat up and all were leaking black fluid from them.Consumer has retained product packaging for possible retrieval.On 24-aug-2021, additional information was provided via a consumer.The consumer noted that she did not use the product and did not get any of the leaking product on her.When she saw the product, it did not look like as what she expected.She put the product on the towel to see if it would get hot.The product was noted to hardly get warm.

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, no batch numbers or return samples were available for evaluation.Without batch reference numbers, a manufacturing and technical assessment cannot be completed for the wraps 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 in process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is a product quality complaint for heat cells damaged/leaking.This subclass represents a potential device malfunction.Lot numbers nor return samples were received; a device malfunction cannot be confirmed.

• Brand Name: THERMACARE JOINT THERAPY 8HR 4CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 12480516
• MDR Text Key: 281017315
• Report Number: 3007593958-2021-00034
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 00305733017241
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/16/2021

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 Expiration Date: 11/30/2023
• Device Model Number: ThermaCare HeatWraps - Flexible
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR