MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MENSTRUAL 8HR; HOT OR COLD DISPOSABLE PACK.

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

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.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.

Event Description

On (b)(6) 2024, a spontaneous report from the united states was received via email regarding a female (age not provided) consumer who used a thermacare menstrual heat wrap.On an unspecified date, the consumer used a thermacare menstrual heat wrap for an unspecified length of application.On an unspecified date, after wearing the heat wrap, the consumer experienced a burn.No additional information was provided.

• Brand Name: THERMACARE MENSTRUAL 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 ; 2294463092
• MDR Report Key: 18759863
• MDR Text Key: 336051686
• Report Number: 3007593958-2024-00010
• 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: 02/20/2024

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
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/22/2024
• 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