NON-ABSORBABLE SURGICAL SUTURES
Received Sep 28, 2014 · Event occurred Jan 1, 2014
Report 2523835-2014-00157 · MDR key 4135699
Device
Generic name
Non-absorbable Suture
Manufacturer
Alcon Precision Device - Sinking SpringModel number
8065307901Catalog number
8065307901
Lot number
908342M
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
A NURSE REPORTED TWO OR THREE PTS HAD A POST-OPERATIVE INFECTION FOLLOWING A PROCEDURE. THE REASON FOR THE INFECTION IS UNK AT THIS TIME. THE PT'S INFO IS UNK AT THIS TIME. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS FACILITY. THIS REPORT REPRESENTS THE SUTURE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.
Additional Manufacturer Narrative
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE. (B)(4).