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

Lot Number GA0939

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Rash (2033); Skin Tears (2516)

Event Date 01/25/2024

Event Type  Injury  

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 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, rash and irritation 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, rash and irritation and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On 25-jan-2024, a spontaneous report from the united states was received via email regarding a 23-year-old female who used a thermacare menstrual heat wrap.On 26-jan-2024, the consumer provided additional information.On 25-jan-2024, the consumer topically applied a thermacare menstrual heat pad for menstrual relief.Approximately 1.5 hours after applying the product she experienced a rash and burn.She also experienced application site redness and a burning sensation.As she removed the heat wrap the top layer of her skin tore off without bleeding.The area was red and sore to the touch.After she removed the heat wrap, the burning sensation stopped which turned into pain.For treatment, she applied neosporin to the area and then a bandage.As of 26-jan-2024, the area was less sore and overall, her symptoms were improving.

• Brand Name: THERMACARE MENSTRUAL
• 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 ; 2294463091
• MDR Report Key: 18704898
• MDR Text Key: 335372320
• Report Number: 3007593958-2024-00007
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: GA0939
• Date Manufacturer Received: 01/25/2024
• 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 Age: 23 YR
• Patient Sex: Female
• Patient Weight: 86 KG