MAUDE Adverse Event Report: CHURCH & DWIGHT CO. TROJAN LATEX ULTRA RIBBED LUBRICATED CONDOMS

Model Number	NOT AVAIL.
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684); Unspecified Tissue Injury (4559)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
This spontaneous report (2025-cdw-01121, (b)(6)) from the united states of america was reported by a 24-year-old female consumer via chat and followed up by a survey, who reported it caused bodily injury and urinary tract infection after using the trojan latex ultra ribbed lubricated condoms.On 24-apr-2025, the consumer reported initiating the use of trojan latex ultra ribbed lubricated condoms once for birth control as per the direction of her primary care recommendation.Later, the consumer reported via chat that she experienced bodily injury that occurred on (b)(6) 2025.She alleged that the product caused urinary tract infection.Additionally, the consumer reported in the survey on june 30, 2025, "very quick after using, burning, pain while after urinating.Blood in urine.Side pain." the consumer stated she did seek medical attention from two different hospitals and was admitted into the hospital.She had ultrasound, blood cp and urine revaluation done and received medication (iv/oral) (unspecified).Her symptoms lasted 2 weeks.No additional information was available.The action taken with trojan latex ultra ribbed lubricated condoms was not applicable.The outcome of the events was recovered.
Additional Manufacturer Narrative
Not avail.
Event or Problem Description
This spontaneous report ((b)(4), (b)(6)) from the united states of america was reported by a 24-year-old female consumer via chat and followed up by a survey, who reported it caused bodily injury and urinary tract infection after using the trojan latex ultra ribbed lubricated condoms.The consumer's medical history and the concomitant medications were not reported.On 24-apr-2025, the consumer reported initiating the use of trojan latex ultra ribbed lubricated condoms once for birth control as per the direction of her primary care recommendation.Later, the consumer reported via chat that she experienced bodily injury that occurred on (b)(6) 2025.She alleged that the product caused urinary tract infection.Additionally, the consumer reported in the survey on june 30, 2025, "very quick after using, burning, pain while after urinating.Blood in urine.Side pain." the consumer stated she did seek medical attention from two different hospitals and was admitted into the hospital.She had ultrasound, blood cp and urine revaluation done and received medication (iv/oral) (unspecified).Her symptoms lasted 2 weeks.Her symptoms lasted for 2 weeks.At the time of this report, her symptoms had resolved.New information was received on july 7, 2025 - as per reporter (consumer), prior to the use of the condom they were having hormone issues [unspecified] and their physician recommended they discontinue the use of contraceptive pills and use condoms for birth control.Following use of first condom, consumer experienced pain and blood in urine within a day of product use; consumer was hospitalized for 2 or 3 nights.No additional information was available.The action taken with trojan latex ultra ribbed lubricated condoms was not applicable.The outcome of the events was recovered.Note: documentation provided by reporter cites "hospital stay & bed charges", however the duration of the stay is not present.

• Brand Name: TROJAN LATEX ULTRA RIBBED LUBRICATED 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: 22480095
• Report Number: 2280705-2025-01121
• Device Sequence Number: 12928743
• Product Code: HIS
• UDI-Device Identifier: 00022600949510
• UDI-Public: 022600949510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/22/2026

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: NOT AVAIL.
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 04/22/2026
• 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: Other; Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female