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 Itching Sensation (1943); Peeling (1999); Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2022

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 "noted blisters on her skin where the wrap was touching." the cause of the consumer stating she "noted blisters on her skin where the wrap was touching" 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 (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 26-year-old female who used a thermacare menstrual 8hr heat wrap.The consumer was health and did not smoke.The consumer was allergic to sulfonamides.Concomitant products included a multivitamin.On (b)(6) 2022, the consumer used a thermacare menstrual 8hr heat wrap applied against her underwear and then attached it to wear around her abdomen.On (b)(6) 2022, after four to five hours of wearing the heat wrap and when she came back from work, she experienced itching on her skin underneath the patch.While she itched, she realized that her skin was coming up.She removed the wrap and examined her skin.She noted blisters on her skin where the wrap was touching.The skin looked burned to her.She noted she had second degree burns on her pubic area.She had been keeping the area clean but had not sought medical care or performed any other therapies.She noted she did not have any broken skin prior to wearing the heat wrap and did not use any creams or ointments prior to suing the heat wrap.When she felt itching, she went to scratch the skin and it started peeling off.As of (b)(6) 2022, the blisters had popped, and her symptoms persisted.

• 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 ; 4234142221
• MDR Report Key: 15601057
• MDR Text Key: 301729526
• Report Number: 3007593958-2022-00067
• 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: 10/13/2022

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 Model Number: ThermaCare HeatWraps - Menstrual
• Device Lot Number: GA0426 N
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/13/2022
• 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
• Treatment: MULTIVITAMIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female