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

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 308275450
• Report Number: 2280705-2022-01878
• Device Sequence Number: 1
• Product Code: HIS
• 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: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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: Male