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

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 01/01/2023

Event Type  Injury  

Event Description

On 21-may-2023, a spontaneous report from the united states was received via email regarding a female (age not provided) consumer who used a thermcare menstrual 8hr heat wrap.Medical history included menstrual cramps.Concomitant products were not provided.On an unspecified date in 2023, the consumer used a thermacare menstrual 8hr heat wrap for menstrual cramps.On an unspecified date in 2023, after applying the heat wrap, the consumer suffered discomfort from using the heating pad.She was left with an injury on her pubic area due to an excessive burn.She experienced pain and had insecurity from the burn.

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend was identified for the subclass adverse event safety request for investigation for menstrual product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

• 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: 17108764
• MDR Text Key: 317131159
• Report Number: 3007593958-2023-00034
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 05/21/2023
• 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 Sex: Female