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

Model Number 482027

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.If information is provided in the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 stress urinary incontinence.It was reported that after implant, the patient experienced pain, recurrence, urinary urgency, frequency and nocturia.Post-operative patient treatment included additional surgeries including implantation of a sling, and small intestine resected and detubularized, used to fashion a cap which was secured to bladder to create new, augmented bladder.

• 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: 8846154
• MDR Text Key: 152792964
• Report Number: 9617613-2019-00130
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2004
• Device Model Number: 482027
• Device Catalogue Number: 482027
• Device Lot Number: 02A29B520004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• 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
• Treatment: 7832200 IN-FAST BONE SCREWS/ANCHOR, LOT# 352771
• Patient Outcome(s): Required Intervention
• Patient Weight: 72