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

Model Number	NOT AVAIL.
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
This spontaneous report (2024-cdw-01489, 07177586) from the united states of america was reported by a consumer (age and gender unspecified) who developed an acquired immunodeficiency syndrome (aids) after using the trojan condoms unspecified.On an unspecified date, the consumer initiated trojan condoms unspecified.After using the condom (device ineffective), the consumer developed an acquired immunodeficiency syndrome (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 event used a trojan condom and got aids was not applicable.

• Brand Name: TROJAN CONDOMS UNSPECIFIED
• Common Device Name: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO.,; 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: 20307959
• Report Number: 2280705-2024-01489
• Device Sequence Number: 11949582
• Product Code: HIS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: NOT AVAIL.
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: NOTAVAIL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT AVAIL.
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown