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

Model Number	00022600940500
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report (2022-cdw-01502, (b)(6)) from the united states of america was reported by a consumer (age and gender unspecified) and was received via food and drug administration (fda) medwatch program, who experienced permanent sexually transmitted disease (sti) and a defect in the product coincident with trojan ultra ribbed condoms.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer used trojan ultra ribbed condoms for the first sexual experience in years.On (b)(6) 2022, the consumer developed a permanent sti and realized the defect, which was not viewed at the time of the product's use.No additional information was available.The action taken with the trojan ultra ribbed condoms was not applicable.The outcome of the event a permanent sti was unknown.The outcome of the event a defect in them was not applicable.

• Brand Name: TROJAN ULTRA RIBBED CONDOMS
• Common Device Name: TROJAN CONDOMS
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15594290
• Report Number: 2280705-2022-01502
• Device Sequence Number: 2277778
• Product Code: HIS
• UDI-Device Identifier: 00022600940500
• UDI-Public: 00022600940500
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 00022600940500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown