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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 10/07/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that the patient had a xenograft pelvic floor graft implanted for treatment of pelvic organ prolapse.The patient reports that they have had recurring infections and other health problems since the graft was implanted.

Manufacturer Narrative

Date of event: exact date unknown, maude report mw5104980 filed on october 7, 2021.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: maude report mw5104980.(b)(4).The complaint device was not be returned for evaluation; 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.

• Brand Name: XENFORM
• Type of Device: 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): TEI BIOSCIENCES INC; 7 elkins street; boston MA 02127
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13225929
• MDR Text Key: 283607047
• Report Number: 3005099803-2021-08204
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female