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

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

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 07/12/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a boston scientific retropubic tvt (tension-free vaginal tape) mesh was implanted into the patient on (b)(6) 2010, for the treatment of chronic stress urinary incontinence.After the procedure, the patient has ongoing mixed urinary incontinence, for which the patient wear pads most of the time.The patient also experienced nocturia, polyuria, and long-term back pain that had no treatment at all.The patient's dyspareunia was also getting worse.In may 2021, the patient developed stabbing pain in the lower abdomen, worsening vaginal pain, and bowel issues, which are possible symptoms of proctalgia fugax.Additionally, recurrent urinary tract infections, vulval itchiness, and constipation were also experienced by the patient.

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: other: tga device incident report reference no.84233; submitted to tga (therapeutic goods administration).Block h6: patient code (b)(6) captures the reportable event of recurrent uti's.

• 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: 17455079
• MDR Text Key: 320370730
• Report Number: 3005099803-2023-04048
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female