MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿; MESH, SURGICAL, POLYMERIC

Model Number 482047

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Alternative summary report for exemption e2013038.Procode: ftl.Reporting period: march 1, 2019 through april 30, 2019.Total number of events: 4 (2 new event reports, 2 supplemental event reports).Total events per brand name: pelvicol (3 events), ugytex (1 events).New events per brand name: pelvicol (2 events).If information is provided in the future, a supplemental report will be issued.

Event Description

Asr exemption e2013038.The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of recurrent pelvic relaxation.It was reported that after implant, the patient experienced an intraoperative perforation of the left external iliac requiring 3 sutures through the area of the vein.

• Brand Name: MESH TSL - PELVICOL¿
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8642112
• MDR Text Key: 146117651
• Report Number: 9617613-2019-00066
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2005
• Device Model Number: 482047
• Device Catalogue Number: 482047
• Device Lot Number: 03B14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 05/24/2019
• 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
• Patient Outcome(s): Required Intervention