MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN BARESKIN CONDOMS 24 CT

Model Number 2260099853

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

This report and the information submitted under this report do not constitute an admission that the device or church & dwight co., inc.Or any of its employees caused or contributed to the event described herein or that the event as reported to church & dwight co., inc.Actually occurred.

Event Description

The consumer alleges that two condoms from the same box of trojan bareskin condoms had broken.The condoms broke on the body of the condoms down the sides during intercourse.The consumer also stated that she had sought medical attention from planned parenthood and had an hiv and other tests done.She further stated the hiv test was negative.She was told by planned parenthood that the other results would take 7-10 business days to be available.She said that planned parenthood stated that if she had not heard from them, that no news was good news.This product would not be expected to be associated with stds; however, in the absence of medical records, we cannot eliminate the potential involvement of the condom.This contact will be reported conservatively, as this can be a serious injury.

• Brand Name: TROJAN BARESKIN CONDOMS 24 CT
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): OKAMOTO INDUSTRIES, INC.; 1 nishiyama, itabashi-cho; ryugasaki, japan|ibaraki-pref. 301-0 801; JA 301-0801
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 12274227
• MDR Text Key: 266965898
• Report Number: 2280705-2021-00034
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00022600998532
• UDI-Public: 00022600998532
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260099853
• Device Lot Number: CZ0277K5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1