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

Model Number	2260095321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report (2022-cdw-00149, (b)(6)) from the united states of america was reported by a male consumer whose condom broke during their intercourse and got a rash coincident with (b)(6) condoms.The consumer medical history and concomitant medications were not reported.On (b)(6) 2022 an hour prior to this report, the consumer applied (b)(6) condoms for intercourse with a male partner.He stated that during intercourse, the condom broke and was not sure if he had been in direct contact with the partner.He indicated that he had gotten a rash.He did not know the history of his partner.No additional information available.The action taken with (b)(6) condoms was not applicable.The outcome of the event condom broke during their intercourse was not applicable.The outcome of the event in getting a rash was unknown.

• Brand Name: TROJAN LATEX ULTRA RIBBED LUBRICATED CONDOMS
• Common Device Name: LUBRICATED CONDOMS
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton, NJ 08540
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08540
• MDR Report Key: 14521310
• Report Number: 2280705-2022-00149
• Device Sequence Number: 5488141
• Product Code: HIS
• UDI-Device Identifier: 00022600900238
• UDI-Public: 00022600900238
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2022

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
• Device Model Number: 2260095321
• Distributor Facility Aware Date: 05/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male