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

Device Problem Material Fragmentation (1261)

Patient Problem Sexually Transmitted Infection (4555)

Event Type  Injury  

Event Description

This spontaneous report 2022-cdw-01521 (b)(6) from the united states of america was reported by a female consumer (age unspecified) who experienced sexually transmitted disease (std) and condom ripping coincident with trojan bareskin condoms unspecified.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated some of the trojan bareskin condoms unspecified to have sex with a random partner.She got a sexually transmitted disease (std).She noticed it ripped after sex and her partner's semen was dripping out of the condom, and they did not put anything on the condom.She stated that she had discarded product (both used and unused).No additional information was available.The action taken with the trojan bareskin condoms unspecified was not applicable.The outcome of the event, sexually transmitted disease (std) was unknown.The outcome of the event condom ripped was not applicable.

• Brand Name: TROJAN BARESKIN CONDOMS UNSPECIFIED
• Type of Device: 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: 15614978
• MDR Text Key: 301914544
• Report Number: 2280705-2022-01521
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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 This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female