MAUDE Adverse Event Report: ANGELINI PHARMA INC. THERMACARE HEAT THERAPY MENSTRUAL HEAT THERAPY; PACK, HOT OR COLD, DISPOSABLE

Lot Number GA0734

Patient Problems Caustic/Chemical Burns (2549); Localized Skin Lesion (4542)

Event Date 11/08/2023

Event Type  Injury  

Event Description

I used "thermacare heat therapy, menstrual pain therapy" otc air activated heat wraps.The directions state to not use them more than 8 hours, so i used them almost exactly 8 hours and took it off.It ended up burning me (i think burning is the right word to use here, but it looks like a chemical burn to be specific.I didn't feel pain at the time at all and didn't have any discomfort).I have open wounds now exactly where the pad was placed, in fact, i took pictures and you can see the pattern of the iron/carbon/etc (whatever the contents are inside of the wrap) align exactly with the wounds.Tl/dr: i used as directed and ended up with what appears to be significant chemical burns.Tested positive for covid the same day i used the product (though i don't believe this matters).

• Brand Name: THERMACARE HEAT THERAPY MENSTRUAL HEAT THERAPY
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): ANGELINI PHARMA INC.
• MDR Report Key: 18130645
• MDR Text Key: 328160401
• Report Number: MW5148077
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2023

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 Lot Number: GA0734
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Patient Sequence Number: 1
• Treatment: ALBUTEROL (ALL AS NEEDED); BUDESONIDE; MUCINEX; ROBITUSSEN, AS NEEDED
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White