MAUDE Adverse Event Report: L L. ULTRA THIN CONDOMS

Lot Number 1403/14

Device Problems Break (1069); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Bought a box of l condoms ultra thin.Three out of ten broke out of a box of 12.Threw the other two away.I haven't had a condom break on me in 15 years.

• Brand Name: L. ULTRA THIN CONDOMS
• Type of Device: L. ULTRA THIN CONDOMS
• Manufacturer (Section D): L
• MDR Report Key: 5476460
• MDR Text Key: 39654367
• Report Number: MW5060654
• Device Sequence Number: 1
• Product Code: HIS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Lot Number: 1403/14
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other