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

Model Number 2260095321

Device Problem Break (1069)

Patient Problem Rash (2033)

Event Date 05/08/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 292794055
• Report Number: 2280705-2022-00149
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600900238
• UDI-Public: 00022600900238
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male