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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT CONDOM, PRODUCT CODE: HIS

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CHURCH & DWIGHT CO., INC. TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT CONDOM, PRODUCT CODE: HIS Back to Search Results
Device Problems Break (1069); Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Irritation (1941)
Event Type  Injury  
Event Description
The consumer reports the condoms broke and alleges infection/irritation from the spermicidal lubricant.
 
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Brand NameTROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT
Type of DeviceCONDOM, PRODUCT CODE: HIS
Manufacturer (Section D)
CHURCH & DWIGHT CO., INC.
500 charles ewing boulevard
ewing NJ 08628
Manufacturer (Section G)
CHURCH & DWIGHT CO., INC.
1851 touchstone drive
south chesterfield VA 23834
Manufacturer Contact
stacey harshaw
469 north harrison street
princeton, NJ 08543
6098067868
MDR Report Key8906107
MDR Text Key154732140
Report Number2280705-2019-00015
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
Type of Report Initial
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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