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

Model Number 482212

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

Patient Problems Granuloma (1876); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 symptomatic cystocele and enterocele with urinary stress incontinence.It was reported that after implant, the patient experienced dyspareunia with vaginal cuff granuloma.Post-operative patient treatment included additional surgery that found intact cervix presumed to be retained from hysterectomy despite documentation that hysterectomy had been total.

• 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: 8838667
• MDR Text Key: 152562724
• Report Number: 9617613-2019-00128
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 18257200043224
• UDI-Public: 18257200043224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082235
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2006
• Device Model Number: 482212
• Device Catalogue Number: 482212
• Device Lot Number: 04B21-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• 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