MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN CONDOM UNKNOWN

Device Problem Break (1069)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Consumer reports condom breakage with unconfirmed transmission of a sexually transmitted disease.

Manufacturer Narrative

• Brand Name: TROJAN CONDOM UNKNOWN
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: lynn moody ; 469 north harrison street; princeton, NJ 08543-5297 ; 6098061431
• MDR Report Key: 4469160
• MDR Text Key: 5183059
• Report Number: 2280705-2015-00014
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other