MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT; CONDOM, PRODUCT CODE: HIS

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Irritation (1941)

Event Type  Injury  

Event Description

The consumer reports the condoms broke and alleges infection/irritation from the spermicidal lubricant.

• Brand Name: TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT
• Type of Device: CONDOM, PRODUCT CODE: HIS
• 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: 8906107
• MDR Text Key: 154732140
• Report Number: 2280705-2019-00015
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2019
• 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: N
• Patient Sequence Number: 1