• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482412
Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scarring (2061); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This event was previously submitted on a summary report (e2013038b).  subsequently, medtronic has received additional information which is being submitted via this 3500a. Exemption number: (b)(4). 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 of pelvic organ prolapse, urinary incontinence. It was reported that after implant, the patient experienced blood loss, pain, discomfort, erosion, infection, fistulae, scarring, cystocele, enterocele(prolapse), rejected vaginal graft, unspecified mesh complications, unspecified urinary problems, unspecified bowel problems, recurrence, dyspareunia, unspecified neuromuscular problems, postgraft pain, fibrotic nodule in segment of graft, graft with necrotic material, paravaginal defect, mass effect, banding, and required nonsurgical and additional surgical interventions. The device had been used with tension-free vaginal tape ethicon/ johnson + johnson.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH TSL - PELVICOL¿
Type of DeviceMESH, 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 Key8649770
MDR Text Key146364071
Report Number9617613-2019-00067
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/19/2005
Device MODEL Number482412
Device Catalogue Number482412
Device LOT Number03B02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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

Patient TREATMENT DATA
Date Received: 05/29/2019 Patient Sequence Number: 1
-
-