MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP L/XL 8HR 10CT; HOT OR COLD DISPOSABLE PACK

Model Number ThermaCare HeatWraps - Lower Back & Hip

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Skin Discoloration (2074)

Event Date 04/09/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received from a consumer via email regarding a female consumer (age not provided) who used a thermacare lower back and hip heat wrap.Medical history included use of thermacare heat wraps used as needed for years without issue.Concomitant products included trazodone, bupropion, and duloxetine.On approximately (b)(6) 2022, the consumer topically applied a thermacare lower back and hip heat wrap for an unspecified indication on her back over a high wasted underwear.On (b)(6) 2022, after 8 hours of applying the heat wrap when the consumer took the heat wrap off before she went to bed.She noticed that her back was burned.It was clarified that her husband saw a dark area on her lower back in shape of the product.The area was darker in the areas where the coil would have been.She said it was not red or a burn initially, and the first week the area was uncomfortable.For treatment she had been applying lotion to sooth her skin.As of (b)(6) 2022, the darkness on her skin was fading but it had not return to normal.No further device information was provided as it was discarded.

Manufacturer Narrative

The root cause cannot be identified.The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "after 8 hours of applying the heat wrap when the consumer took the heat wrap off before she went to bed.She noticed that her back was burned".The cause of the consumer stating she received a burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a burn; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE LOWER BACK & HIP L/XL 8HR 10CT
• 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: 14375430
• MDR Text Key: 294664406
• Report Number: 3007593958-2022-00029
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010389
• UDI-Public: 00305733010389
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: ThermaCare HeatWraps - Lower Back & Hip
• Device Lot Number: GA0015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2022
• Initial Date FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUPROPION; DULOXETINE; TRAZODONE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female