MAUDE Adverse Event Report: CHURCH & DWIGHT CO. TROJAN ULTRA THIN SPERMICIDAL CONDOMS

Model Number	00022600927426
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Genital Bleeding (4507)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
A consumer from the united states reported via an online review on (b)(6) 2026 that, following use of trojan ultra-thin spermicidal condoms (12 count), they experienced urethral inflammation and genital bleeding.No further information was provided to permit medical assessment or verification of the reported event.The reporter reported using trojan ultra-thin condoms.As reported by the consumer, following use of the condom, the consumer experienced urethral irritation/inflammation, bleeding from the genital area, severe pain, multiple hospital visits, and multiple catheterizations.The consumer attributed the event to the spermicide contained in the product and stated they do not have a latex allergy.No additional information, medical records, physician diagnosis, treatment details, or product lot information were available to verify the reported event or treatment.However, due to the reported need for medical intervention, including multiple catheterizations and hospital visits, the event was assessed as a serious injury and reported in an abundance of caution.

• Brand Name: TROJAN ULTRA THIN SPERMICIDAL 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: tracy dunn ; 469 north harrison street; princeton, NJ
• MDR Report Key: 25867975
• Report Number: 2280705-2026-00008
• Device Sequence Number: 9846359
• Product Code: HIS
• UDI-Device Identifier: 00022600927426
• UDI-Public: 00022600927426
• 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): 07/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 00022600927426
• 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: 06/20/2026
• Initial Report FDA Received Date: 07/19/2026
• 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: Required Intervention
• Patient Sex: Unknown