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

Model Number	ThermaCare HeatWraps - Flexible
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELNI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11741326
• Report Number: 3007593958-2021-00007
• Device Sequence Number: 11561329
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 00305733017241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention