MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number 72912

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

Patient Problems Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows : lot # : 1229477 device expiration date : 08/31/2026.Device manufacture date : 08/17/2021.Lot # : unknown device expiration date : unknown.Device manufacture date : unknown.Initial reporter zip code : (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted into the patient on (b)(6) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; other pain: pain upon arousal & attempted climax: infections & inflammation inside the bladder not present prior to operation; inability to have intercourse; difficulties with bowel motions; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2015 the patient commenced physiotherapy treatment for the treatment of: continual pain in the groin - like a stabbing pain.Treatment detail: information and suggestions as to what could help alleviate the pain.Patient could not do pelvic floor exercises for the discomfort.Treatment duration: 2 visits.The patient was treated with topical treatment (including oestrogen cream).On (b)(6) 2020 the patient commenced treatment with: creams & pills, enablex pills, amit2% bacl2% diaz2% vaginal cream to alleviate inflammation (in the bladder especially at night as awake every 1 or 2 hours or so with the pain) & vagina.Treatment duration: on going.

• Brand Name: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12929278
• MDR Text Key: 287193145
• Report Number: 3005099803-2021-06857
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72912
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 64 KG