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

Model Number	2260099853
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 12274227
• Report Number: 2280705-2021-00034
• Device Sequence Number: 4686873
• Product Code: HIS
• UDI-Device Identifier: 00022600998532
• UDI-Public: 00022600998532
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2025
• Device Model Number: 2260099853
• Device Lot Number: CZ0277K5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1