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

Model Number 00022600940500

Device Problem Defective Component (2292)

Patient Problem Sexually Transmitted Infection (4555)

Event Date 06/10/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 301637106
• Report Number: 2280705-2022-01502
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600940500
• UDI-Public: 00022600940500
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 00022600940500
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability