MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH SOFRADIM - UGYTEX¿; MESH, SURGICAL, POLYMERIC

Model Number UGY1510

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Scar Tissue (2060); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601)

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 a urogynecological issue.It was reported that after implant, the patient experienced cystocele, prolapse, rectal bleeding, urinary frequency and urgency, trouble urinating, odor, vaginal odor, something poking the vaginal wall, vaginal pressure and bulging, difficulty emptying bladder, urinary retention, nocturia, scar tissue, bowel adhesions, eroded mesh attached to upper vagina, urinary incontinence and occasional leakage.Post-operative patient treatment included revision surgery.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• 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: 8727949
• MDR Text Key: 148985949
• Report Number: 9617613-2019-00106
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGY1510
• Device Catalogue Number: UGY1510
• Device Lot Number: P24341G3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• 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 Weight: 56