MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SLING TRANSOBTURATOR; SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY

Model Number M0068504000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Urinary Frequency (2275); Hematuria (2558)

Event Date 04/09/2015

Event Type  Injury  

Event Description

Reporter states that on (b)(6) 2015 she had a procedure to have a transobturator placed.One year later, she began to experience digestion issues.(b)(6) 2017 she began to experience hematuria, urinary frequency and abdominal pain, that was exacerbated when urinating.She has also experienced bladder infections.Symptoms have not subsided currently.

• Brand Name: OBTRYX SLING TRANSOBTURATOR
• Type of Device: SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7619063
• MDR Text Key: 111864205
• Report Number: MW5077941
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/19/2018

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2017
• Device Model Number: M0068504000
• Device Lot Number: ML00002656
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 73