MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number	M0068302450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implanting physician is: (b)(6).The following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.
Event or Problem Description
It was reported to boston scientific corporation that a xenform tissue repair matrix device was implanted into the patient during an anterior repair, placement of interposition graft (xenform), vault suspension and cystoscopy procedure performed on (b)(6) 2016, for the treatment of rectocele, vaginal vault prolapse and incomplete bladder emptying.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• Brand Name: XENFORM
• Common Device Name: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): INTEGRA LIFE SCIENCES SALES LLC; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16292702
• Report Number: 3005099803-2023-00027
• Device Sequence Number: 6523033
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: 11/30/2018
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Device Lot Number: 0001602004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female