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

Model Number	00022600642039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unspecified date, the consumer used the trojan magnum condoms during intercourse and the condom broke.The consumer states " they used magnum, and it broke during intercourse".The consumer also states "i now have stds.I went to the doctor and contacted a lawyer who will contact you".The action taken with trojan magnum condoms was not available.The outcome of the events broke and did not work was not available.The outcome of the event sexually transmitted infection was not available.
Additional Manufacturer Narrative
Not avail.

• Brand Name: TROJAN MAGNUM CONDOMS
• Common Device Name: 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
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 22857976
• Report Number: 2280705-2025-01427
• Device Sequence Number: 7632144
• Product Code: HIS
• UDI-Device Identifier: 00022600642039
• UDI-Public: 00022600642039
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 00022600642039
• Device Catalogue Number: NOT AVAIL
• Device Lot Number: NOT AVAIL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/21/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown