MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number PCO4VP

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

Report source-other: materials management director casie geiger if information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during umbilical hernia repair procedure, on deployment of the mesh the reinforcement suture connected to the mesh would not work properly causing the mesh to not stay flush with the abdominal wall.There was no patient injury.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9241080
• MDR Text Key: 163913641
• Report Number: 1219930-2019-06042
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514140
• UDI-Public: 10884521514140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1