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	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem 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 device was implanted into the patient on (b)(6) 2018 for treatment of prolapse.As reported by the patient's attorney, the patient experienced unspecified complications.

• 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: 14350684
• Report Number: 3005099803-2022-02530
• Device Sequence Number: 4077760
• 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: 2018
• 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): 05/10/2022

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: 01/31/2021
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Device Lot Number: C003688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Female