MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN POLYURETHANE SUPRA BARESKIN CONDOMS; CONDOM, SYNTHETIC

Model Number 00022600902423

Device Problem Device Slipped (1584)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

This spontaneous report (b)(4) from the united states of america was reported by a female consumer (age unspecified) who felt the condom like plastic, not comfortable, and it came off inside her while using trojan polyurethane supra bareskin condoms.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer used trojan polyurethane supra bareskin condoms.While using it, she felt it was like plastic and not comfortable.She also stated that the condom came off inside her.However, she caught it in time.No additional information was available.The action taken with trojan polyurethane supra bareskin condoms was not applicable.The outcome of the event felt the condom like plastic and not comfortable was unknown.The outcome of the event it came off inside her was not applicable.

• Brand Name: TROJAN POLYURETHANE SUPRA BARESKIN CONDOMS
• Type of Device: CONDOM, SYNTHETIC
• 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 08268
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 16100686
• MDR Text Key: 308669338
• Report Number: 2280705-2022-01930
• Device Sequence Number: 1
• Product Code: MOL
• UDI-Device Identifier: 00022600902423
• UDI-Public: 00022600902423
• 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: Other
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 00022600902423
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female