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

Lot Number GA0790

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

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 a burn/blisters.The cause of the burn/blisters 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-(b)(4)).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/blisters and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 22-nov-2023, a spontaneous report from the united states was received via telephone regarding a 53-year-old female who used a thermacare lower back & hip l/xl heat wrap.On 27-nov-2023, additional information was received.At approximately 9:00 or 9:30 in the morning on (b)(6) 2023, the consumer topically applied a thermacare lower back & hip l/xl heat wrap directly to her skin of her lower back for an unspecified indication.Approximately at 2 to 2:30 pm the same day, the consumer removed the heat wrap.She felt a stinging after removal of the heat wrap which she thought it was due to the residual heat from the device.Later that night she was getting into the shower, and she noticed 8 to 10 small blisters across her back.As of (b)(6) 2023, some of the blisters were intact and others had opened and leaked clear fluid.For treatment she used triple antibiotic ointment, kept it clean, and kept it wrapped.As of (b)(6) 2023, she had not seen the doctor since they were busy.She was unsure fi she would see a doctor since she was healing.She noted she followed the package directions and she reported the heat of the product caused the blisters.She experienced difficulty to wear jeans due to the location of the blisters and her tattoo looked different.No additional information was provided.

• 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: 18348300
• MDR Text Key: 330814323
• Report Number: 3007593958-2023-00077
• 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: 12/18/2023

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: GA0790
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/18/2023
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DICLOFENAC.; GABAPENTIN.; MULTIVITAMIN.; PAXIL (PAROXETINE).; SINGULAR (MONTELUKAST).
• Patient Age: 53 YR
• Patient Sex: Female