MAUDE Adverse Event Report: ANGELINI THERMACARE HEATWRAP (UNSPECIFIED); HOT OR COLD DISPOSABLE PACK.

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Skin Infection (4544)

Event Type  Injury  

Event Description

On 03-mar-2022, a spontaneous report from the united states was received via email from a consumer regarding a consumer (age and gender not provided) who used a thermacare heat wrap.Medical history and use of concomitant products were not provided.On an unspecified date, the consumer topically applied an unspecified thermacare heat wrap (lot number and expiration date were not provided) for an unspecified indication.On an unspecified date, after 4 hours of application of the product, the consumer experienced burns.The consumer had burns on both ends of where the heat wrap had touched the skin.For treatment, the consumer purchased medical supplies, cleaned the areas, and applied band-aids.The consumer noted that they would "probably have to go to the hospital" as "it was clearly infected even after keeping it properly cleaned and having band-aids over it.".

Manufacturer Narrative

There is limited device specific information provided, no batch number, product type, or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

• Brand Name: THERMACARE HEATWRAP (UNSPECIFIED)
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; scott.hughes@bridgeschc.com; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 13952784
• MDR Text Key: 288852418
• Report Number: 3007593958-2022-00018
• Device Sequence Number: 1
• Product Code: IMD
• 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: 03/28/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/30/2022
• 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