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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TROJAN TROJAN FIRE AND ICE CONDOM

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TROJAN TROJAN FIRE AND ICE CONDOM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Reaction (2414)
Event Date 09/28/2013
Event Type  Injury  
Event Description

Used 2 trojan fire and ice condoms on (b)(6) 2013. When i woke on (b)(6) 2013 my eyes were swollen. I thought i may have come in contact with poison ivy and i used oatmeal on my face. When i washed, i felt a rash in my pubic area. I began taking allergy pills. On (b)(6) 2013 before i went to work, i used another one. After showering, my face had swollen more to the extent i could see my sinuses and my eyes were almost shut. I went to the (b)(6) and was given a prednisone shot and pills. On (b)(6) 2013, i ate hot and spicy plantain chips and the next morning my eyes were red and swollen. Before using this product, i had never been allergic to any red or cayenne type peppers which i had used almost everyday. I have had a free chemical peel to various parts of my body including pubic area. Thighs, breasts, face, neck and ears because of the product. Three weeks into this itching and rash and i am not a happy camper. Dates of use: (b)(6) 2013. Diagnosis or reason for use: protection. Event reappeared after reintroduction: yes.

 
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Brand NameTROJAN
Type of DeviceTROJAN FIRE AND ICE CONDOM
MDR Report Key3533091
MDR Text Key3973431
Report NumberMW5033545
Device Sequence Number1
Product Code HIS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/22/2013
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received10/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No

Patient TREATMENT DATA
Date Received: 10/22/2013 Patient Sequence Number: 1
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