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

Model Number M0068502000

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

Patient Problem Insufficient Information (4580)

Event Date 10/24/2005

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6), 2005, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a advantage system was implanted during vaginal hysterectomy with bilateral salpingectomy, oophorectomy, laparoscopic sacrocolpopexy, posterior colporrhaphy, midurethral sling placement, cystoscopy procedures performed on (b)(6) 2005, to treat a patient with uterovaginal prolapse, stress incontinence, rectocele, cystocele, enterocele.There were no patient complications during the implant procedure.The patient tolerated the procedure well, was brought to recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unspecified injury.

• Brand Name: ADVANTAGE 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15915273
• MDR Text Key: 304799389
• Report Number: 3005099803-2022-07138
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729719564
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/05/2022

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
• Device Expiration Date: 07/01/2008
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0ML5071101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female