MAUDE Adverse Event Report: CHURCH & DWIGHT CO. 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
This spontaneous case was reported by a consumer from germany via social media.The reporter (consumer) reported using trojan magnum condoms.As per the reporter, "we bought your magnums and out of two 3 packs four condoms tore through intercourse.I caught a sti (sexually transmitted infection) due to that incident." as per the social media conversation, the reporter stated, "i have already been and now have chlamydia due those condoms torn".The reporter further stated, "i developed symptoms shortly after using the product.No additional information was available.Medical history and concomitant medication - unknown.
Additional Manufacturer Narrative
Not avail.

• Brand Name: TROJAN MAGNUM CONDOMS
• 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 evision ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 23677064
• Report Number: 2280705-2025-01788
• Device Sequence Number: 18388057
• Product Code: HIS
• UDI-Device Identifier: 00022600642039
• UDI-Public: 00022600642039
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2025

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: TT5032Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/30/2025
• 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
• 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