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

Model Number UNKNOWN PELVICOL PRODUCT

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

Patient Problems Cramp(s) (2193); Discharge (2225); Injury (2348); Prolapse (2475); Blood Loss (2597)

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 of mixed incontinence and symptomatic vaginal wall prolapse.It was reported that after implant, the patient experienced recurrence with recurrent cystocele and rectocele formation, lower abdominal cramping, and bloody vaginal discharge.Post-operative patient treatment included additional surgery.The device had been used with an unknown suburethral sling.

• 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: 9606661
• MDR Text Key: 177980047
• Report Number: 9617613-2020-00005
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PELVICOL PRODUCT
• Device Catalogue Number: UNKNOWN PELVICOL PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• 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