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

Model Number	00022600902423
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 2280705-2022-01930
• Device Sequence Number: 6092678
• Product Code: MOL
• UDI-Device Identifier: 00022600902423
• UDI-Public: 00022600902423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 00022600902423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female