MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN PARIETEX

Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Berrevoet f; doerhoff c; muysoms f; hopson s; muzi mg; nienhuijs s; kullman e; tollens t; schwartz mr; leblanc k; velanovich v; jorgensen ln; (2017) a multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch: interim results of the panacea study.Medical devices evidence and research.10:81-88, 2017 purpose: this study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (parietex¿ composite ventral patch [pco-vp]).Patients and methods: a single-arm, multicenter prospective study of 126 patients undergoing open ventral hernia repair with the pco-vp was performed.A total of 126 patients were enrolled between may 3, 2013, and july 10, 2014, at 12 centers in europe and the us.The majority (87.3%) of patients was treated for an umbilical hernia, while 12.7% were treated for epigastric hernia.Device malfunction = 1, the mesh did not open fully and had to be removed.The fascial incision was enlarged by 1.5 cm, and a second mesh was deployed.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6647221
• MDR Text Key: 77792114
• Report Number: 9617613-2017-05100
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2017
• 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