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

Model Number UNK PELVICOL

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Scarring (2061); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Reason for mesh implantation: stress urinary incontinence and bladder prolapse.Alleged complications post device implant, pain, erosion, infection, urinary problems, bowel problems, recurrence, bleeding, neuromuscular problems and vaginal scarring.Mesh revision surgery: underwent vaginal vault prolapse repair for stress urinary incontinence and recurrent vaginal prolapse.Following mesh revision, developed recurrent vaginal prolapse and chronic pain and underwent the following additional surgeries: additional implant (pelvicol and gynecare) surgery: (b)(6) 2006: underwent vaginal sacrocolpopexy, anterior and posterior repair, sacrospinous ligament fixation, cystoscopy and tvt-o under general endotracheal anesthesia.Mesh revision surgery: (b)(6) 2008: underwent repair for recurrent vaginal prolapse and chronic pain.

• Brand Name: 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6716693
• MDR Text Key: 80131065
• Report Number: 9617613-2017-05106
• 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: Attorney
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Device Lot Number: 05B04-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention