MAUDE Adverse Event Report: NULATEX SDN. BHD. L.UNK; CONDOM

Lot Number NOT AVAILABLE

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

Consumer contacted and stated that two condoms broke.No injury was reported.

• Brand Name: L.UNK
• Type of Device: CONDOM
• Manufacturer (Section D): NULATEX SDN. BHD.; kluang johor,, 86000 ; MY 86000
• MDR Report Key: 10264176
• MDR Text Key: 198525712
• Report Number: 1216894-2020-00003
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1