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

Device Problem Break (1069)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report (b)(4) from the united states of america was reported by a consumer (age and gender unspecified) whose condom broke and developed acquired immunodeficiency syndrome (aids) after using the trojan condoms unspecified.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer used trojan condoms unspecified.The consumer alleged that the condom broke, and the consumer got aids.No additional information was available.The action taken with trojan condoms unspecified was not applicable.The outcome of the event aids was unknown.The outcome of the device breakage was not applicable.

• Brand Name: TROJAN CONDOMS UNSPECIFIED
• 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 08268
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ
• MDR Report Key: 16851343
• MDR Text Key: 314361258
• Report Number: 2280705-2023-00761
• 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: 04/23/2023

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
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other