MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST; HOT OR COLD DISPOSABLE PACK.

Lot Number 202112A1

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ulcer (2274); Full thickness (Third Degree) Burn (2696)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, the batch number provided at intake is not a valid batch for thermacare heat wraps.Without a valid batch reference number 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 adverse event safety request for investigation.The manufacturing operation employs quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn to the consumers' abdomen.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 41-year-old female who was using a thermacare neck/shoulder/wrist heat wrap.Medical history included diabetes, hypertension, and allergies to erythromycin and bactrim (trimethoprim/sulfamethoxazole).Concomitant products included an unspecified antihypertensive.On (b)(6)2022, the consumer applied the thermacare neck/shoulder/wrist heat wrap to her abdomen for approximately 1 hour.She fell asleep with the device on.On (b)(6) 2022, she woke up with a burning sensation.She removed the heat wrap and she had a red burn at the application site.On (b)(6) 2022, she went to an emergency room (er).She was told that she had a 3rd degree burn and was prescribed an oral antibiotic.On (b)(6) 2022, she returned to the er due to her wound opening.The wound was cleaned, and she was prescribed an antibiotic ointment.She was advised to have a follow-up visit if her symptoms did not improve.As of (b)(6) 2022, the consumer's skin was closed, intact, red, tender to the touch, and she and not been seen for further evaluation.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• 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: 15201041
• MDR Text Key: 297626538
• Report Number: 3007593958-2022-00052
• 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: 08/10/2022

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
• Device Lot Number: 202112A1
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/10/2022
• 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
• Treatment: UNSPECIFIED ANTIHYPERTENSIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 113 KG