MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC LIFESTYLE ULTRA LUBRICATED CONDOMS

Lot Number 1708081916

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 09/27/2018

Event Type  malfunction  

Event Description

Lifestyle condoms provided in clinic were reported to break multiple times during correct use in intercourse.Staff in clinic tried putting condoms over their hands.Two staff members reported the condoms breaking on their hands.Reason for use: safe sex.

• Brand Name: LIFESTYLE ULTRA LUBRICATED CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC
• MDR Report Key: 7922285
• MDR Text Key: 122306335
• Report Number: MW5080208
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Lot Number: 1708081916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 50