AMPLIFIED CONDOMS MULTIPACK "NIRVANA COLLECTION"

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for AMPLIFIED CONDOMS MULTIPACK "NIRVANA COLLECTION" manufactured by Trojan / Church And Dwight Co Inc..

Event Text Entries

[140283813] It is somewhat embarrassing to write this publicity, but i feel like i need to make a public service announcement. The trojan amplified condom we used seems to have literally burned my genitals. Imagine a sunburn inside and out. This was confirmed by both my dr and a second physician. During usage, the sensation was not particularly pleasant, but not awful, either. The lubricant is supposed to be "warming and tingling" and it felt like that. However, the next day, my vulva and the inside of my vagina felt unusually raw. That evening, i used a mild lubricant to soothe, but it didn't seem to help much. That lubricant was the blossom organics natural lubricant, an fda registered compliant product. On the second day, my vulva was burning all day. The pain was not focused around my urethra, and it was not related to my urinary habits. My urine also appeared and smelled normal. A uti seemed unlikely, but i thought i might have a yeast infection or some other infection and scheduled a dr's appt. On day three, i started seeing what appeared like white "gunk" - like toilet tissue residue - but still no discharge. Skipping forward to my gynecologist visit, i expected something like an infection due to disturbances to the ph or microbiota. Instead, the dr examined me thoroughly and called in a colleague. She took samples for a slide from all over my vagina and examined them. It turns out that i have an actual burn inside my vagina and all over my vulva. The residue that was falling into my urine and wiping off is basically like the peeling of a sunburn. According to the drs, the new skin underneath appears healthy, and there is likely no long-term damage. However, there is basically nothing i can do either. Until the damaged skin peels away and the new skin is fully healed, i am likely to continued to be in pain. They gave me an estimate of 2-4 weeks before i can resume sexual activity, as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085192
MDR Report Key8456255
Date Received2019-03-26
Date of Report2019-03-22
Date of Event2019-03-17
Date Added to Maude2019-03-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAMPLIFIED CONDOMS MULTIPACK "NIRVANA COLLECTION"
Generic NameCONDOM
Product CodeHIS
Date Received2019-03-26
Lot NumberTT8101U
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerTROJAN / CHURCH AND DWIGHT CO INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-26

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