MAUDE Adverse Event Report: BARD PERFIX PLUG; MARLEX MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330); Numbness (2415)

Event Date 03/25/2015

Event Type  Other  

Event Description

Reporter stated that six months after the implant of both devices in (b)(6) 2015, he has been experiencing pain and numbness with his testicles.He stated that the numbness is more intense after intercourse.He can feel the cord pulling against his testicles.

• Brand Name: PERFIX PLUG
• Type of Device: MARLEX MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 5705314
• MDR Text Key: 46781877
• Report Number: MW5062699
• Device Sequence Number: 1
• Product Code: FTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 64