MAUDE Adverse Event Report: CHURCH & DWIGHT CO.,INC TROJAN GOAT NON-LATEX CONDOM

Model Number	00022600800132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not available.
Event or Problem Description
This spontaneous case was reported by a consumer from the united states of america via sms messaging.The reporter (consumer) reported using trojan goat non-latex condom.As per the reporter, "after using a condom from this pack i got infection and irritation.How do i return this?" no additional information was available.Medical history and concomitant medication - unknown.Note: church and dwight, emailed consumer the ade survey link to complete.In addition, consumer was asked "any medical treatment received? what type of infection did you experience?".Awaiting additional information; however, the case was conservatively assessed as serious (reportable) with limited information on infection.

• Brand Name: TROJAN GOAT NON-LATEX CONDOM
• 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: 23447680
• Report Number: 2280705-2025-01686
• Device Sequence Number: 8188320
• Product Code: HIS
• UDI-Device Identifier: 00022600800132
• UDI-Public: 00022600800132
• 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): 11/03/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 00022600800132
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: KT5155331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/03/2025
• 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