MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP L/XL 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0553

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Skin Inflammation/ Irritation (4545)

Event Date 08/15/2023

Event Type  Injury  

Event Description

On 26-aug-2023, a spontaneous report from the united states was received via email regarding a 75-year-old female who used a thermacare lower back & hip 8hr l/xl heat wrap.On 29-aug-2023, additional information was received from a consumer.Approximately on (b)(6) 2023, the consumer topically applied a thermacare lower back & hip 8hr l/xl heat wrap to her lower back over an undershirt.Approximately after 30 minutes to an hour after application, she developed irritation at the application site and her daughter removed the heat wrap.While removing the heat wrap, round circles burns were seen.On an unspecified date, the consumer spoke to her doctor on the phone who recommended her to keep the area clean and not wear anything that would rub against the area.For treatment she applied cortisone cream daily.A little over a week later, she felt much better.

Manufacturer Narrative

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 a burn.The cause of the consumer a burn is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and 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
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 17714369
• MDR Text Key: 323002645
• Report Number: 3007593958-2023-00061
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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: 09/08/2023

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: GA0553
• Initial Date Manufacturer Received: 08/26/2023
• Initial Date FDA Received: 09/08/2023
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 136 KG