MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN MAGNUM XL CONDOMS UNSPECIFIED; CONDOM, PRODUCT CODE: HIS

Device Problem Break (1069)

Patient Problems Bacterial Infection (1735); Skin Discoloration (2074)

Event Date 05/31/2019

Event Type  Injury  

Event Description

The consumer reports that the condoms keep breaking every time he has sex.Additionally, when he would take the condom off, his penis appeared purple.He sought medical attention from an urgent care center.After having an std test, he was diagnosed with (b)(6).The consumer reported he is fine now and was cleared of (b)(6).

• Brand Name: TROJAN MAGNUM XL CONDOMS UNSPECIFIED
• 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: 8906377
• MDR Text Key: 154741382
• Report Number: 2280705-2019-00017
• 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
• Type of Report: Initial
• Report Date: 07/16/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 08/19/2019
• 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 Age: 13 YR