MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED; TROJON CONDOM

Device Problem Break (1069)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report (2022-cdw-01209, 007595010a) from the united states of america was reported by a male consumer (age unspecified) whose condom was broken and developed a sexually transmitted disease (std) coincident with trojan latex bareskin lubricated condoms (trojan bareskin raw lubricated condoms unspecified).The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer used trojan latex bareskin lubricated condoms (trojan bareskin raw lubricated condoms unspecified).He stated that the condom was broken and he developed std.No additional information was available.The action taken with trojan latex bareskin lubricated condoms (trojan bareskin raw lubricated condoms unspecified) was unknown.The outcome of the sexually transmitted disease was unknown.The outcome of the condom break was not applicable.

• Brand Name: TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED
• Type of Device: TROJON CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 15273245
• MDR Text Key: 298393992
• Report Number: 2280705-2022-01209
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male