MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Urinary Tract Infection (2120)

Event Date 08/31/2013

Event Type  Injury  

Event Description

On (b)(6), (b)(6) had surgery to treat stress urinary incontinence, with insertion of a sling by transobturator procedure.Three days after surgery, (b)(6) had a first cystitis (escherichia coli resistant to ampicillin and ticarcillin).Since then, she has recurrent utis, about one to 6 times per month.Most of the time, the bacteria is gram negative, escherichia coli being the most frequently found in cebus post-surgery in 2013 (16/22 documented cases).Other documented gram positive bacteria were staphylococcus epidermis (2/22), enterococcus faecalis (3/22), and staphylococcus saprophyticus (1/2).On the last cytobacteriological urinary examination performed on (b)(6) 2019, escherichia coli was found resistant to ampicillin, augmentin, selexid, fosfomycin and bactrim.This was consecutive to monitoring visits in (b)(6) hospitals.During the flu period's she has been treated with ofloxacin for 7 days.Since the surgery in 2013, (b)(6) has contacted 3 urologists and every time the answer was: "we can't remove the mesh".This information was not presented in the informed consent signed pre-surgery in 2013.This information is now present in the amended informed consent released in (b)(6) 2016.One proposal to solve the voiding problem was: self- performed intermittent catheterization.The second proposal was "see a psychiatrist".For one year and a half, (b)(6) has developed osteonecrosis of the left femoral head ( stage iv) and needs a surgery for hip prosthesis implantation.The surgeon wants to cure the colibacillosis before surgery.Fda safety report id # (b)(4).

• Brand Name: OBTRYX HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8674797
• MDR Text Key: 147452619
• Report Number: MW5087154
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 75