MAUDE Adverse Event Report: ANGELINI THERMACARE HEATWRAP; HOT OR COLD DISPOSIBLE PACK.

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no product type, no batch number or return sample was available for evaluation.Without a batch reference number 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.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via email regarding a female (age not provided) who used an unspecified thermacare heat wrap.Medical history and concomitant products are not provided.On an unspecified date, the consumer used a thermacare heat wrap.On an unspecified date, after using the product, the consumer experienced a burn from using the heat wrap.No additional information was provided.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: HOT OR COLD DISPOSIBLE 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 ; 4234142221
• MDR Report Key: 15546754
• MDR Text Key: 301235321
• Report Number: 3007593958-2022-00063
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 09/20/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female