MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR S/M 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The root cause cannot be identified.The sample is not available for evaluation; without the physical sample for evaluation, the root cause of the consumer stating ".The chemical was leaking out" cannot be determined.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.This is a product quality complaint for heat cell damaged leaking; risk calculation is major-skin burn.

Event Description

On (b)(6) 2022, a spontaneous report was received from the united states via email from a consumer who obtained a thermacare lower back and hip 8hr sm/m heat wrap.Medical history and concomitant products were not provided.On an unspecified date, after opening the box of heat wraps, the consumer noticed that the product was stamp-cut incorrectly.The heat wrap was still packaged and when the consumer opened the package the chemical was leaking out.No additional information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M 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: 14366042
• MDR Text Key: 294666896
• Report Number: 3007593958-2022-00028
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male