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U.S. Department of Health and Human Services

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

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CHURCH & DWIGHT CO., INC. TROJAN PLEASURE PACK CONDOMS UNSPECIFIED Back to Search Results
Lot Number TT8320
Device Problem Break (1069)
Patient Problems Erythema (1840); Rash (2033)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
The consumer states that her and her boyfriend were using this product and that it snapped. She then alleges that she had a red rash the next day. She specified that it was the (b)(6) condom. We are reporting this conservatively in the absence of additional information from the consumer.
 
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Brand NameTROJAN PLEASURE PACK CONDOMS UNSPECIFIED
Type of DeviceCONDOM
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing, nj
Manufacturer (Section G)
CHURCH & DWIGHT CO., INC.
1851 touchstone road
south chesterfield, va
Manufacturer Contact
stacey harshaw
469 north harrison street
princeton, nj 
8067868
MDR Report Key10428585
MDR Text Key204404181
Report Number2280705-2020-00025
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
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2021
Device Lot NumberTT8320
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2020
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? No
Type of Device Usage Unkown

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