MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN ULTRA THIN CONDOMS

Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This spontaneous report (b)(4) from the united states of america was reported by a male consumer (age unspecified) whose condom was slipping off coincident with using trojan ultra thin condoms.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer used trojan ultra thin condoms for intercourse.The consumer indicated that one of the condoms fell off during intercourse.No additional information was available.The action taken with trojan ultra thin condoms and the outcome of the event were not applicable.

• Brand Name: TROJAN ULTRA THIN CONDOMS
• 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 08268
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 16002068
• Report Number: 2280705-2022-01878
• Device Sequence Number: 18057291
• Product Code: HIS
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• 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: 12/19/2022
• 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
• Patient Sex: Male