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 Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an uphold implant and an upsylon y-mesh implant were implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; rectal pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; other pain: urinary tract infections surgical interventions: on an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant for the following purpose: to have the mesh removed as it impacted the bladder and caused erosion and pain, which is why patient had to have it removed; she suffered lots of pain and bleeding.Nonsurgical treatments: on (b)(6) '2021 the patient commenced pain medication: cefalexin sandoz 500mg for the treatment of urinary tract infection.Treatment duration: 5 days.On (b)(6) 2021 the patient commenced incontinence medication: curam duo amoxicillin tri hydrate 500mg clavulanic 125 mg as the other medication was not the right medication to treat the infection.Treatment duration: 5 days.

• 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: 12930818
• MDR Text Key: 286920972
• Report Number: 3005099803-2021-06845
• 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: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 84 KG