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

Model Number M0068505001

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Granuloma (1876); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); No Code Available (3191)

Event Date 02/21/2012

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2012, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system was implanted into the patient during a procedure performed on (b)(6) 2012.As reported by the patient's attorney, after the implantation, the patient has experienced mesh erosion, pain in the back, vagina, pelvis, groin and anal; dyspareunia, apareunia at times, offensive vaginal discharge, infection in the vagina and bladder, damage to ureter and bladder, recurrent prolapse, recurrent urinary incontinence, urinary retention, urinary frequency, difficulty and pain defecating.The patient had not been taken any pain medication due to many allergies, however, she had been taking tropical treatment such as oestrogen cream.The patient had revision surgery on (b)(6) 2012 and subsequently, underwent excision of suburethral fibrosis and granuloma.Boston scientific has been unable to obtain additional information regarding the event to date.

• Brand Name: OBTRYX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11133639
• MDR Text Key: 225596215
• Report Number: 3005099803-2020-06653
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: ML00000242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR