MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number 640590

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2023

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 for lower back and hip wraps.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.There are pre-identified risk factors that could cause skin irritation listed in the hazard analysis (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.

Event Description

On 22-dec-2023, a spontaneous report from canada was received via email regarding a female (age not provided) who used a thermacare lower back & hip heat wrap.Additional information was received on 27-dec-2023.Approximately 1.5 to 2 months ago (relative to (b)(6) 2023) the consumer topically applied a thermacare lower back & hip heat wrap topically to her back for an unknown indication which wore for approximately 2 hours.A few days after wearing the heat wrap, she developed a big bump and irritation.Several days later she went to an emergency room (er).The er doctor gave her a cream to sue with a gauze pad.Her wound had puss and she experienced itching.On (b)(6)2023, she went to her family doctor and was given a prescription for antibiotics.She could not lie on her back.As of (b)(6) 2023, she had not picked up the prescription yet.No additional information was provided.

• Brand Name: THERMACARE HEAT WRAP
• 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): ANGELIN; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18489619
• MDR Text Key: 332601732
• Report Number: 3007593958-2023-00093
• 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: 01/10/2024

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: 640590
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/10/2024
• 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 Sex: Female