MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS 24 CT

Model Number 2260099853

Device Problem Break (1069)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

The consumer alleges that three condoms broke in a row and he/she (unsure of gender) now has (b)(6).

• Brand Name: TROJAN BARESKIN CONDOMS 24 CT
• Type of Device: TROJAN BARESKIN CONDOMS 24 CT
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone drive; south chesterfield VA 23834
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 8907712
• MDR Text Key: 154790457
• Report Number: 2280705-2019-00020
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• 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: 07/10/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2260099853
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/19/2019
• 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