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  

Manufacturer Narrative

Product return was not received.A valid production code hasn't been provided by the reporter, therefore no further product investigation possible.Product return availability not established.Full evaluation will occur upon receipt of returned product.

Event Description

Condom broke inside partner, had a thumb sized hole [device breakage].Ultra thin condoms are softer and thinner than last versions, a tiny tear got much larger since the condom was not strong [device physical property issue].No adverse event reported [no adverse event].Case description: a non-event - spontaneous report was received via e-mail on 30-jun-2019 from a male consumer, age unknown, stating he used l.Male condoms, ultra thin version, and the product broke inside while being used with his wife.The condom had a thumb sized hole in it when he inspected it.He stated they were much softer and thinner than previous versions, and a tiny tear got much larger since the condom was not strong.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: 8955354
• MDR Text Key: 204193579
• Report Number: 1216894-2019-00001
• 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: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/30/2019
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1