MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. OBTRYX TRANSOBTURATOR MIDURTHRAL SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number M0068504000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Autoimmune Reaction (1733); Pain (1994); Thrombosis (2100); Patient Problem/Medical Problem (2688)

Event Date 08/01/2018

Event Type  Injury  

Event Description

In 2007 obtryx boston scientific tvto placed at (b)(6) by dr (b)(6) with zero discussion or disclosure of polypropylene mesh being placed as he called it tape with no warning of risks.Three months later hospitalized with dvt that turned into bilateral pulmonary embolism and nearly died.Dr refused to acknowledge it could have been that procedure and unfortunately i believed him.Fast forward ten years of chronic health issues, immune problems, pelvic, abdominal pain, irritable bowel syndrome, etc and in (b)(6) of this year realizing through many tests that my pain and bladder are the tvto which had been shrinking, tightening and my body's immune response to the mesh.(b)(6) 2018 had partial removal and still have long road and other surgeries ahead now due to almost complete incontinence.

• Brand Name: OBTRYX TRANSOBTURATOR MIDURTHRAL SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 8226928
• MDR Text Key: 132495177
• Report Number: MW5082893
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2009
• Device Model Number: M0068504000
• Device Lot Number: OML6112703
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 91