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

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

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report (2023-cdw-01018, 007798811a) from the united states of america was reported by a 39-year-old female consumer who developed herpes after using the trojan ultra thin condoms.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer used trojan ultra thin condoms.After using the condom, she developed herpes.No additional information was available.The action taken with the trojan ultra thin condoms was not applicable.The outcome of the event was unknown.

• Brand Name: TROJAN ULTRA THIN CONDOMS
• Type of Device: CONDOM
• 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: 17254198
• MDR Text Key: 318446492
• Report Number: 2280705-2023-01018
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female