CONDOM WITH NONOXYNOL-9 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-28 for CONDOM WITH NONOXYNOL-9 * manufactured by *.

Event Text Entries

[495685] Per consumer's letter, "it is of great concern to me that the fda has not banned the production of male condoms lubricated with the spermicidal nonoxynol-9. These condoms have not been proven to provide protection against pregnancy and have shown to potentially increase the risk of contracting hiv if used rectally. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004187
• MDR Report Key: 757449
• Date Received: 2006-07-28
• Date of Report: 2006-05-18
• Date Added to Maude: 2006-09-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CONDOM WITH NONOXYNOL-9
• Generic Name: *
• Product Code: LTZ
• Date Received: 2006-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 745345
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-07-28