MAUDE Adverse Event Report: COVIDIEN LLC MESH SYMBOTEX 9CM ROUND; MESH, SURGICAL, POLYMERIC

Catalog Number SYM25

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 05/15/2019

Event Type  Injury  

Event Description

On (b)(6) 2015 a hernia mesh product was implanted.Approx 18 to 24 months later, i started experiencing pain and soreness around the umbilical area (location of entry).When pressure is applied to the navel.I can feel something sticking me.It feels like a needle is sticking me.Sought the consult of a new surgeon to correct the issue of whatever is protruding that is sticking me when pressure is applied to the navel.Fda safety report id# (b)(4).

• Brand Name: MESH SYMBOTEX 9CM ROUND
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 8599655
• MDR Text Key: 144797830
• Report Number: MW5086518
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SYM25
• Device Lot Number: POL0772X
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Weight: 90