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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 CT
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CHURCH & DWIGHT CO., INC. TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 CT Back to Search Results
Model Number 2260094732
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 10/29/2020
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 states that one of the condoms broke and that he was with a partner that may have had genital herpes.We are reporting this as a malfunction with potential exposure to genital herpes and in the absence of additional information from the consumer.
 
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Brand Name
TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 CT
Common Device Name
CONDOM
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing NJ 08628
MDR Report Key10787927
Report Number2280705-2020-00028
Device Sequence Number4177856
Product Code HIS
UDI-Device Identifier00022600947325
UDI-Public00022600947325
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K120286
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/04/2020
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 Model Number2260094732
Device Lot NumberTT0182D
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/29/2020
Initial Report FDA Received Date11/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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