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 Problems Pain (1994); Dyspareunia (4505)

Event Date 07/08/2014

Event Type  Injury  

Manufacturer Narrative

Block g2: mhra adverse incident report reference no (b)(4); although the country of event is australia, the event was submitted to mhra (medicines and healthcare products regulatory agency) by the physician.Block h6: imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2330 captures the reportable event of pain.

Event Description

It was reported to boston scientific corporation that an advantage system mesh was implanted into the patient on (b)(6) 2014.After implantation, the patient developed pain requiring medications to treat persistent pelvic pain.It was also reported that the patient has dyspareunia.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18387797
• MDR Text Key: 331289716
• Report Number: 2124215-2023-71509
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

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: 05/31/2017
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00002351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female