TROJAN CONDOMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for TROJAN CONDOMS manufactured by Church & Dwight Company.

Event Text Entries

[35058592] On (b)(6) 2015, i purchased (b)(6) condoms from a local (b)(6). When i got home, i realized that the condoms were expired. The expiration date on the was 10/2015. I went back to the store the next day. They were willing to let me exchange them. However, most of the condoms in the store were expired. I was able to find a package that was not expired and brought the issue to the attention of a customer service representative at the store. Next, i called church & dwight company (the manufacturers of (b)(6) condoms) to alert them on the situation. I made the call on (b)(6). I received a call back on december 29th. I warned them that a distributor is selling their expired product. The woman who called me back, (b)(6), did not even ask me the location of the distributor. Even after i asked her if she would like to know the name and address of the distributor that is selling expired products. She said that she was just told to call me back and if i want, i can speak to the quality control department myself. I told her that i was at work and asked her to forward the info the their quality control department, but she said that if want to, i can do that myself and wished me a good day. This is a very dangerous matter. The expiration date is very hard to see (it's white on white) and luckily i have noticed it and me and my boyfriend are std free. However, if this was used by other people, perhaps ones that do not have a steady partner, the outcome may have been very bad. Please feel free to contact me with any additional questions at (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058854
MDR Report Key5341299
Date Received2015-12-29
Date of Report2015-12-29
Date of Event2015-12-20
Date Added to Maude2016-01-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTROJAN CONDOMS
Generic NameTROJAN CONDOMS
Product CodeHIS
Date Received2015-12-29
Device Expiration Date2015-10-31
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCHURCH & DWIGHT COMPANY


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.