MAUDE Adverse Event Report: PROXY BIOMEDICAL LIMITED UPSYLON¿; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was opened and tested.There was no procedure or patient involvement.According to the complainant, a small cut was made on the midline section of the sacral tail of the mesh, and the mesh tore/unraveled down the midline.

• Brand Name: UPSYLON¿
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7328376
• MDR Text Key: 102091138
• Report Number: 3005099803-2018-00521
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C003575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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