MAUDE Adverse Event Report: ANGELINI THERMACARE MENSTRUAL 8HR 3CT; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0426

Device Problem Insufficient Information (3190)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Skin Infection (4544)

Event Date 12/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a spontaneous report was received from the united states via telephone regarding a 32-year-old female who used a thermacare menstrual 8hr heat wrap.The consumer declined to provide information regarding medical history or use of concomitant products, except that she was allergic to lexapro (escitalopram) and she used thermacare approximately a year prior without event.On (b)(6) 2022, the consumer applied a thermacare menstrual 8hr heat wrap to her stomach.On (b)(6) 2022, additional information was provided by a consumer.On (b)(6) 2022, after applying the heat wrap, the consumer received two burns.On (b)(6) 2022, it was clarified that after wearing the product for 5 hours she removed it.When she removed the heat wrap, she had red spots.The area became worse.Subsequently, on (b)(6) 2022 she went to a clinic.She was diagnosed with first and second degree burns and a skin infection which was at the application site.She was prescribed oral cipro (ciprofloxacin) twice daily for 5 days.She was not recommended to follow up unless it became worse.She had not used the heat wrap since (b)(6) 2022.As of (b)(6) 2022, her issues continued.No additional information was provided.

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 she has " first and second degree burns and a skin infection which was at the application site".The cause of the consumer stating she received burns and a skin infection is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of blisters or other skin irritations.This is an adverse event for a burn and skin infection; risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE MENSTRUAL 8HR 3CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr.; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 16035448
• MDR Text Key: 306011173
• Report Number: 3007593958-2022-00093
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2022

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: GA0426
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/22/2022
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 118 KG