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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number 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 50-year-old female consumer who used a thermacare lower back and hip s/m heat wrap.Medical history included hypertension, chronic back pain, seasonal allergies, she "needed a liver transplant", and use of thermacare on (b)(6) 2022 without issue.Allergies included toradol.The reporter declined to provide details regarding use of concomitant products except that she took 15 medications.On approximately (b)(6) 2022, she applied a thermacare heat wrap to her skin on her lower back.On 13-dec-2022, additional information was received from a consumer.After wearing the product for 7 hours, she thought something was burning.When she removed the product, she felt it was stuck to her skin.She noted it "burnt my whole lower back." on (b)(6) 2022, it was clarified that when she removed the patch, she saw an area of redness which was the dimension of the patch.She had a blister that was larger than a half-dollar coin.She had been monitoring the burn at home and had not seen a doctor for her symptoms.She did not perform any home treatments.She felt the area was healing well over the past two days.As of (b)(6) 2022, the blistered area had turned into more of a scab.She continued to have redness.No further 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 ; 4234142221
• MDR Report Key: 16035649
• MDR Text Key: 306068398
• Report Number: 3007593958-2022-00092
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 15 UNSPECIFIED MEDICATIONS.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 48 KG