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

Lot Number GA0734

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Ulcer (2274)

Event Date 11/01/2023

Event Type  Injury  

Event Description

On 12-nov-2023, a spontaneous report from the united states was received via email regarding a 33-year-old female who used a thermacare menstrual 8hr heat wrap.On 13-nov-2023, additional information was received from the consumer.On 08-nov-2023, the consumer topically applied a thermacare menstrual heat wrap applied with the adhesive side towards her pants before she went to work.Her underwear was between the heat wrap and her lower abdomen.After wearing the heat wrap for 8 hours, she noticed 9 red marks also reported as what appeared to be chemical burns that were in the pattern of the packaged material inside of the heat wrap that were painful.As the evening progressed, the 9 spots worsened and became open wounds.Some of the spots were less size of a dime, and the largest one was about the size of a quarter.She noted the open wounds appeared to be getting infected, however it was clarified that she meant that one area had redness around it and it was concerning for infection.Subsequently, she used neosporin on the area and the redness resolved.She did not go see a doctor because she believed they would just tell her to do what she was currently doing.As of 13-nov-2023, the open wounds were scabbed over and looked a lot 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 skin irritation and burn; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• 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 ; 2294463085
• MDR Report Key: 18276869
• MDR Text Key: 329889764
• Report Number: 3007593958-2023-00072
• 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: 12/06/2023

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: GA0734
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; BUDESONIDE NASAL RINSE
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female