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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC TROJAN CONDOMS UNSPECIFIED
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CHURCH & DWIGHT CO., INC TROJAN CONDOMS UNSPECIFIED Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Burning Sensation (2146); Sexually Transmitted Infection (4555)
Event Type  Injury  
Event Description
This spontaneous report (2023-cdw-00378, 007711570a) from the united states of america was reported by a female consumer (age unspecified) who experienced gonorrhea, burning and bumps on her vagina after using trojan condoms unspecified.The consumer's medical history and the concomitant medications were not reported.On an unspecified date, the consumer used trojan condoms unspecified.Later, she experienced burning and bumps in vagina.She alleged that it gave her gonorrhea.No additional information was available.The action taken with trojan condoms unspecified was not applicable.The outcome of the events was not recovered.
 
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Brand Name
TROJAN 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 08268
Manufacturer Contact
jon evison
469 north harrison street
princeton, NJ 08543
MDR Report Key16425425
MDR Text Key310411696
Report Number2280705-2023-00378
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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