MAUDE Adverse Event Report: NYLON SURGICAL NET; NYLON SURGICAL MESH

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Date 06/12/2013

Event Type  Injury  

Event Description

Surgery to repair right inguinal hernia.Felt a searing/tearing sensation at the site as soon as the surgery was completed.Returned to the surgeon, dr.(b)(6) at (b)(6) hospital to ask about the pain and he said he "saw" nothing.I have lower back problems and erroneously attributed my back problems to the cause of the pain.Recently my g.P.Dr (b)(6) and i thought to separate the two and he prescribed a nerve block injection.The doctor who performed the nerve block said he could see the nylon net via x-ray when he made the injection.The searing and tearing are gone.

• Brand Name: NYLON SURGICAL NET
• Type of Device: NYLON SURGICAL MESH
• MDR Report Key: 5878320
• MDR Text Key: 52304038
• Report Number: MW5064102
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 79