MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN-ENZ CONDOMS

Lot Number KT1085265

Device Problems Difficult to Remove (1528); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This spontaneous report (2022-cdw-01823, 007665981a) from the united states of america was reported by a female consumer (age unspecified) who had condom stuck inside her coincident with the use of trojan-enz condoms.The consumer's medical history and the concomitant medications were not reported.On an unspecified date in (b)(6) 2022 (3 weeks prior to this report), the consumer used trojan-enz condoms.While using the condom, it got stuck inside her for quite some time.After 3 weeks, it came out.No additional information was available.The action taken with trojan-enz condoms and the outcome of the event was not applicable.Company comment: there was no mention of medical treatment received in the communication with the consumer.Although not explicitly stated by the consumer, church & dwight considers this to be a case of condom slippage and is reporting conservatively.

• Brand Name: TROJAN-ENZ 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: 16004400
• MDR Text Key: 308174918
• Report Number: 2280705-2022-01823
• 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: 12/01/2022

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
• Device Lot Number: KT1085265
• 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