MAUDE Adverse Event Report: JON.EVISON@CHURCHDWIGHT.COM TROJAN CONDOMS UNSPECIFIED

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report (2023-cdw-01265, 007835318a) from the united states of america was reported by a consumer (age and gender unspecified) who developed acquired immunodeficiency syndrome (aids) after using trojan condoms unspecified.On an unspecified date, the consumer used trojan condoms unspecified during sex.The consumer alleged that they developed aids after using a condom.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 event used the product and got aids (device failure) was not applicable.

• Brand Name: TROJAN CONDOMS UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): JON.EVISON@CHURCHDWIGHT.COM; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 17608831
• MDR Text Key: 321802004
• Report Number: 2280705-2023-01265
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2023
• 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): Other