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

Model Number	2260099853
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer states that he purchased a 24 pack of trojan bareskin condoms.He alleges that out of the first five condoms, three ripped.He further stated that he has (b)(6).This is being reported as a malfunction with a risk of exposure to a sti.

• Brand Name: TROJAN BARESKIN CONDOMS
• Common Device Name: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 10722165
• Report Number: 2280705-2020-00027
• Device Sequence Number: 1667973
• Product Code: HIS
• UDI-Device Identifier: 00022600998532
• UDI-Public: 00022600998532
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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
• Device Model Number: 2260099853
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1