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

Model Number M0068502120

Device Problem Material Integrity Problem (2978)

Patient Problems Micturition Urgency (1871); Pain (1994); Anxiety (2328); Depression (2361); Prolapse (2475); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting facility is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e232401 - used to capture the reported event of fecal incontinence.E0206 - used to capture the reported event of loss of enjoyment of life.E2330 - used to capture the reported events of severe pelvic pain, pain and suffering.E1304 - used to capture the reported event of urinary urgency problems.E1405 - used to capture the reported event of dyspareunia.E2015 - used to capture the reported event of vaginal atrophy.E020201 - used to capture the reported event of anxiety.E020202 - used to capture the reported event of depression.The following imdrf impact codes capture the reportable events of: f1202 - used to capture the reported event of physical impairment and permanent physical injury.F12 - patient had filed a legal claim for injuries related to the device.

Event Description

It was reported to boston scientific corporation that an advantage fit blue system device was implanted into the patient during a procedure performed on (b)(6) 2020.The patient claims the following injuries as a result of the procedure: severe pelvic pain, failed sling, cystocele, rectocele, incontinence, fecal incontinence, dyspareunia, urinary urgency problems vaginal vault prolapse, vaginal atrophy, and other harms that will be determined during the course of discovery.Furthermore, the patient claims to have suffered the following damages as a result of the implantation of the prior designated pelvic mesh products: economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, permanent physical injury, and more.

• Brand Name: ADVANTAGE FIT BLUE 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: 17196286
• MDR Text Key: 317809434
• Report Number: 3005099803-2023-03029
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• 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
• Type of Report: Initial
• Report Date: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0025018377
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female