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

Model Number 482047

Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Pain (1994); Scarring (2061); Discharge (2225); Distress (2329); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); Bowel Perforation (2668); Alteration In Body Temperature (2682); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Previously reported as asr.Additional information:updates to relevant history, event description, patient weight, and all patient codes.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 prolapse and stress urinary incontinence.It was reported that after implant, the patient experienced vaginal vault prolapse/cystocele, continuous pain, extrusion, unspecified urinary problems, unspecified bowel problems, fistulae, dyspareunia, vaginal scarring, blood loss, adhesions, nocturia, atrophy, postoperative bleeding, temperature, discomfort, drainage, mental and physical stress, damage to vaginal vault, bowel perforation, chronic constipation, hypotension, pelvic trauma, rectocele, and incontinence.The device had been used with microvasive des precision twist anchor sys.Post-operative patient treatment included numerous nonsurgical and additional surgical interventions as well as additional implant and duloxetine and gavaprin medications for nerve pain.

• 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: 8768102
• MDR Text Key: 150387837
• Report Number: 9617613-2019-00116
• 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: 07/08/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2002
• Device Model Number: 482047
• Device Catalogue Number: 482047
• Device Lot Number: 01A03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• 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
• Patient Age: 58 YR
• Patient Weight: 64