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

Model Number ThermaCare HeatWraps - Menstrual

Device Problem Insufficient Information (3190)

Patient Problems Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)

Event Date 09/01/2022

Event Type  Injury  

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 "experienced a blister burn".The cause of the consumer stating she experienced a blister burn" 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.

Event Description

On 02-sep-2022 a spontaneous report from the united states was received via telephone regarding a female in her 30's who used a thermacare menstrual 8hr heat wrap.Medical history included asthma attacks and prior use of thermacare without incident for years.Concomitant products were not provided.On an unspecified date in (b)(6) 2022, the consumer topically applied a thermacare menstrual heat wrap.On an unspecified date in (b)(6) 2022, the consumer experienced a blister burn.One cell inside the wrap became hotter than the others and she developed a burn after applying it.The consumer was noted to have used the heat wrap correctly and without a heating pad.The consumer's mother was a nurse who treated her symptoms with antibiotic ointment and applied honey in between applications of the antibiotic ointment.On (b)(6) 2022, the consumer's blister popped and was purple in color.No additional information was provided.

• Brand Name: THERMACARE MENSTRUAL 8HR
• 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: 15458866
• MDR Text Key: 300300838
• Report Number: 3007593958-2022-00059
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733020029
• UDI-Public: 00305733020029
• 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: 09/20/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Menstrual
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/20/2022
• Date Device Manufactured: 05/02/2022
• 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: 30 YR
• Patient Sex: Female