MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR PERMACOL 4X18 1MM; MESH, SURGICAL, POLYMERIC

Model Number 5418-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Lot number not provided, udi not provided, re-processing information not provided, since the lot number was not provided, this information cannot be determined, occupation of initial reporter not provided.

Event Description

According to the reporter: the patient had erosion of the mesh that was inserted during a ventral rectopexy procedure she underwent in (b)(6) 2011.In 2014 the patient developed symptoms of erosion and investigations revealed this.She underwent revision surgery in (b)(6) 2015.

• Brand Name: PERMACOL 4X18 1MM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer (Section G): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6152681
• MDR Text Key: 61664070
• Report Number: 9617613-2016-00142
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5418-100
• Device Catalogue Number: 5418-100
• Device Lot Number: 10B17-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention