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 Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 04/12/2024

Event Type  Injury  

Event Description

On 15-apr-2024 a spontaneous report from the united states was received via telephone regarding a 27-year-old female consumer who used a thermacare menstrual 8hr heat wrap.On 16-apr-2024, 17-apr-2024, and 23-apr-2024 additional information was provided.Medical history included allergies to penicillin and prior use of thermacare without event.On (b)(6) 2024 the consumer topically applied a thermacare menstrual heat wrap to her underwear.Approximately one-half hours after applying the heat wrap the consumer experienced a burning sensation and stinging sensation, like her skin was ripping.When she took off the patch, she noticed a large bubble that was approximately 3 inches, the size of one of the heat cells on her lower abdomen.She clarified that the burn she had was under one heat cell and not across the entirely of the patch.On (b)(6) 2024, her pain increased, and she went to an emergency room (er).She was diagnosed with first- and second-degree burns.In the emergency room she was given ketorolac tromethamine, neosporin, and clindamycin with a prescription to continue it at home.She was advised to dress the wound with neosporin and cover with a yellow solution gauze covered with non-adherent gauze daily.Since she left the er, her pain had continued to become worse, and she had difficulty walking.The area which was red had spread and the wound turned yellow and green.On (b)(6) 2024, the consumer went to urgent care, and she was given intramuscular injection of ceftriaxone.She was told to discontinue the clindamycin and prescribed her doxycycline.A wound culture was performed, and results were expected in 5-7 days.She was recommended to continue to apply neosporin and gauze wraps and take ibuprofen for pain.The skin all around the burn still hurts and has not improved.On (b)(6) 2024, the consumer went to urgent due to fatigue and dizziness.She was diagnosed with a yeast infection due to the antibiotics after a vaginal swab culture.She was given a dose of fluconazole, clotrimazole cream, and meclizine for the dizziness.Her dizziness was improved and she experienced flatulence with use of the medication.She noted the burn was starting to scab up and was significantly better.Her pain had improved and was mild.She still walked in a way in order to protect the wound.

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.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 ((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 and 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 ; 2294463093
• MDR Report Key: 19213332
• MDR Text Key: 341391695
• Report Number: 3007593958-2024-00022
• 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: 04/26/2024

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: GA0734
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 100 KG