MAUDE Adverse Event Report: TROJAN / CHURCH AND DWIGHT CO INC. AMPLIFIED CONDOMS MULTIPACK "NIRVANA COLLECTION"

Lot Number TT8101U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pain (1994); Peeling (1999); Burning Sensation (2146)

Event Date 03/17/2019

Event Type  Injury  

Event Description

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.

• Brand Name: AMPLIFIED CONDOMS MULTIPACK "NIRVANA COLLECTION"
• Type of Device: CONDOM
• Manufacturer (Section D): TROJAN / CHURCH AND DWIGHT CO INC.
• MDR Report Key: 8456255
• MDR Text Key: 140283813
• Report Number: MW5085192
• Device Sequence Number: 1
• Product Code: HIS
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2021
• Device Lot Number: TT8101U
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 113