XENFORM SOFT TISSUE REPAIR MATRIX
Received Apr 12, 2018 · Event occurred Mar 1, 2018
Report 3005099803-2018-00963 · MDR key 7424534
Device
Generic name
Mesh, Surgical, Non-synthetic, Urogynecologic For Apical Vaginal And Uterine Pro
Manufacturer
Tei Biosciences IncorporatedModel number
M0068302470Lot number
0001510026
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PATIENT IDENTIFIER IS (B)(4). STUDY NAME: U9920 XENFORM A/A POSTMARKET. THE DEVICE IS IMPLANTED AND NOT EXPECTED TO 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 REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT EXPERIENCED URINARY TRACT INFECTION. SHE WAS TREATED WITH ANTIBIOTICS AND THE EVENT RESOLVED ON (B)(6) 2018.