MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN ULTRA; CONDOM

Device Problem Defective Component (2292)

Patient Problem Sexually Transmitted Infection (4555)

Event Date 06/10/2022

Event Type  Injury  

Event Description

Trojan 3 pack ultraribbed were purchased from family dollar in (b)(6).A defect in them, which wasn't viewed in time cause my first sexual experience in years to leave me with a permanent sti.

• Brand Name: TROJAN ULTRA
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.
• MDR Report Key: 15462590
• MDR Text Key: 300471245
• Report Number: MW5112189
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: Black Or African American