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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Peeling (1999); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via email regarding a female consumer of unspecified age who used thermacare menstrual 8hr.Medical history included prior use of thermacare menstrual heat wraps twice without issue.No allergy information or concomitant product use was specified.On an unspecified date, the consumer topically applied a thermacare menstrual 8hr heat wrap to her lower abdomen.She did not indicate whether she applied the wrap against her underwear as directed by the package instructions.At an unspecified time after application of the heat wrap while using the restroom she noted a searing pain at the application site and indicated that her skin had "blistered off with no warning." no other clinical or treatment information was reported.The consumer did not indicate the outcome of the adverse event.No further information was received after (b)(6) 2022.

• Brand Name: THERMACARE MENSTRUAL 8HR
• Type of Device: HOT OR COLD DISPOSIBLE 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: 15847121
• MDR Text Key: 304176543
• Report Number: 3007593958-2022-00075
• 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: 11/14/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/22/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female