XENFORM SOFT TISSUE REPAIR MATRIX
Received Aug 15, 2018 · Event occurred Jan 28, 2015
Report 3005099803-2018-02560 · MDR key 7785092
Device
Generic name
Mesh, Surgical, Non-synthetic, Urogynecologic For Apical Vaginal And Uterine Pro
Manufacturer
Boston Scientific - MarlboroughModel number
M0068302470Lot number
0001411010
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR
- Urinary Tract Infection
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
THE PATIENT¿S ID IS (B)(6). STUDY NAME: (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM TISSUE REPAIR MATRIX WAS USED DURING A PELVIC FLOOR RECONSTRUCTION WITH APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT EXPERIENCED A LOWER URINARY TRACT INFECTION AND WAS TREATED WITH AUGMENTIN. THE EVENT WAS RESOLVED ON (B)(6) 2015.