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

Model Number	M0068318220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Legal product liability number: (b)(6).The exact date of the event is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.This event was reported by the patient's legal representation.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 or Problem Description
It was reported to boston scientific corporation that an upsylon y-mesh was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• Brand Name: UPSYLON Y MESH KIT
• Common Device Name: 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: 13794697
• Report Number: 3005099803-2022-01260
• Device Sequence Number: 5063593
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Device Lot Number: C002497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female