MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL MESH, SURGICAL

Model Number UNKNOWN PERMACOL MESH

Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discharge (2225); Injury (2348); Blood Loss (2597); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment. It was reported that after implant, the patient experienced repeat reconstructive surgery when she underwent intraperitoneal ureterosacral ligament reattachment, enterocele and rectocele repair by rectovaginal septal reconstruction using gynemesh, perineorrhaphy and cystoscopy for her stage iii-bp recurrent pelvic organ prolapse with enterocele and rectocele, sharp pain on the right side of the vagina high and deep into it, some vaginal bleeding and spotting with a yellow discharge, persistent pain on the right side, continued constipation, and reported self catheterization with no spontaneous voids.

• Brand Name: MESH TSL - PERMACOL
• Type of Device: MESH, SURGICAL
• 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: 8095500
• MDR Text Key: 128071009
• Report Number: 9617613-2018-00112
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PERMACOL MESH
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/21/2018 Patient Sequence Number: 1