inforMED
InjuryPAJ

XENFORM SOFT TISSUE REPAIR MATRIX

Received Feb 20, 2018

Report 3005099803-2018-00260 · MDR key 7282811

Device

Generic name

Mesh, Surgical, Non-synthetic, Urogynecologic For Apical Vaginal And Uterine Pro

Model number

UNK166

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Information
  • No Information

Narrative

Description of Event or Problem

AS REPORTED BY THE PATIENT¿S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.