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

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

On (b)(6) 2023, a spontaneous report from social media was received regarding a consumer (age and sex not provided) who used a thermacare menstrual 8 hr heat wrap.On an unspecified date, the consumer topically applied a thermacare menstrual 8 hr heat wrap.On an unspecified date less than 6 hours after applying the heat wrap, the consumer took it off and noticed a burn on the lower abdomen.The consumer would bleed when using the restroom because of the scabs adhering to the underwear.The consumer felt the heat wrap was different from others.No additional information was provided.

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass.Adverse event safety request investigation.The manufacturing operation employs quality control procedures, which include in-process testing, thermal testing, and visual inspection to ensure the quality of the packaged product.This is an adverse event for a burn of the product.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): ANGELINI; 1231 wyandotte drive; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 17262617
• MDR Text Key: 318479615
• Report Number: 3007593958-2023-00041
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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