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

Model Number ThermaCare HeatWraps - Flexible

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass heat cells damaged leaking.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is a quality complaint liquid leaking.A risk calculation cannot be determined as there is no lot number available for this potential device malfunction.

Event Description

On (b)(6) 2021 , a spontaneous report from the united states was received from a consumer regarding a female of unknown age who was using the thermacare joint therapy 8hr 4ct.Medical history and information regarding usage of concomitant products were not provided.On an unspecified date, the consumer opened her last few packages of thermacare joint therapy 8hr 4ct (lot number: ldy5938067042048; expiration date 30-apr-2023), the liquid dripped off the patch and got on her hands.As of 01-apr-2021, no additional information was provided as the consumer declined further participation.

• Brand Name: THERMACARE JOINT THERAPY 8HR 4CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELNI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 1100 market street suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 11741326
• MDR Text Key: 252685717
• Report Number: 3007593958-2021-00007
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 00305733017241
• 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: 04/28/2021

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: 04/30/2023
• Device Model Number: ThermaCare HeatWraps - Flexible
• Device Lot Number: LDY5938067042048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention