MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MENSTRUAL HEATING PAD; PACK, HOT OR COLD, DISPOSABLE

Patient Problems Chest Pain (1776); Dyspnea (1816); Unspecified Infection (1930); Skin Discoloration (2074); Caustic/Chemical Burns (2549); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/04/2023

Event Type  Injury  

Event Description

I put in a thermacare menstrual heating pad inside my panties but over a t-shirt and wore it for 6 hrs.I could feel it getting hot, but i kept it on because i didn't have any pain meds on me.When i got home, i checked the area (as well as my lower back where i was also wearing one) and saw that the area had sm burn marks.I called thermacare and reported the incident, but tried to treat it myself.But the area became infected and extremely tender to the touch, so i went to the er to have it examined.Because i was also experiencing shortness of breath and chest pain, they admitted me to (b)(6).Blood test showed that i was infected with mansonella ozzardi and that i suffered a chemical burn due to product leakage.I was given 3 iv doses of clindamyacin and sent home on augmentin bc i am allergic to doxycycline.The abd wound was covered with colloidal gel and sterile bandages, and i bought colloidal bandages from amazon to continue my treatment at home.Now i have several am black marks on my mid and llq(lower left quadrant) of my abdomen that still remain tender.I did report this to (b)(6) on july 9 and august 25, 2023.

• Brand Name: THERMACARE MENSTRUAL HEATING PAD
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE
• MDR Report Key: 18613885
• MDR Text Key: 334367158
• Report Number: MW5150908
• 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: 01/28/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Patient Sequence Number: 1
• Treatment: AUGMENTIN; BANDAGES; CLINDAMYCACIN
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American