MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS, LLC LIFESTYLES ZERO LUBRICATED LATEX CONDOM

Model Number LUBRICATED LATEX

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  malfunction  

Event Description

Condoms broke while in use by the patient.Pt reports that two condoms broke.The same lot number pulled in the clinic and broke easily.The packaging is hard to read, lot# is 1706082716.Additional lots that broke afterward are: 1708081916 and 1610141122.

• Brand Name: LIFESTYLES ZERO LUBRICATED LATEX CONDOM
• Type of Device: CONDOM
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS, LLC; 1635 industrial rd.; dothan AL 36303
• MDR Report Key: 7964726
• MDR Text Key: 123691261
• Report Number: 7964726
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LUBRICATED LATEX
• Device Lot Number: 1706082716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2018
• Event Location: Other
• Date Report to Manufacturer: 10/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA