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

Model Number	00022600642145
Medical Device Problem Code	Device Slipped (1584)
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 case was reported by a 32-year-old female consumer from the united states of america via phone and followed up by trojan ecstasy breakage survey and global ade survey.The reporter (consumer) reported using trojan magnum condoms, used one condom in (b)(6) 2025 for intercourse.As per reporter, "i was using the magnum trojans and i had intercourse, and the condom slipped off inside me.We had a few issues with other condoms in the box not rolling down properly.Now i have irritation in my vagina, i peed very cloudy, i noticed stomach pains which turned out to a uti/ yeast infection and std.The condom is still inside of me.I have to go get a pap smear to get it removed".The reporter further reported "the condoms slipped off inside me during intercourse.At the time of global ade survey completion ((b)(6) 2025), when asked "what symptoms did you experienced?", reporter stated "at least five days after using the product, irritation in my vagina, i peed very cloudy, i noticed stomach pain which turned out to a uti/ yeast infection and std.When asked " how long did the symptoms last? reporter stated, "still experiencing symptoms the condom is still inside me".The reporter stated she did seek medical attention (a pap smear) reporter reported she stopped using the product on (b)(6) 2025.No additional information was available.Medical history and concomitant medications- when asked in the ade survey, "please list any known medical conditions or any relevant lifestyle factors (e.G., liver and/or kidney", reporter response was "none", are you currently taking any other medications? please list medications, dosage, method of administration" reporter reported ""i am on antibiotics, i dont know three names off the top of my head", and "do you have any known allergies? please list", reporter response was "none".

• 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: 23520548
• Report Number: 2280705-2025-01721
• Device Sequence Number: 21235779
• Product Code: HIS
• UDI-Device Identifier: 00022600642145
• UDI-Public: 00022600642145
• 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): 11/10/2025

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: 00022600642145
• Device Catalogue Number: NOT AVAIL
• Device Lot Number: KT4145319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/11/2025
• 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 Age: 32 YR
• Patient Sex: Female