PROBE DE 6 SERLING
Received Oct 16, 2015 · Event occurred Jul 1, 2015
Report 2523190-2015-00106 · MDR key 5157817
Device
Generic name
M5 - General Surgery
Manufacturer
Integra York, Pa Inc.Catalog number
10-8-ST
Lot number
UNKNOWN
Product problems
- Particulates
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THAT DURING THE FIRST WASH ALL PROBES WERE DISCOLORED. IN USE, USER REALIZED THEY WERE PEELING OFF CAUSING RESIDUES IN THE WOUND WHICH REQUIRED THEM TO CLEAN OUT THE WOUND AGAIN. (B)(6) 2015 CUSTOMER REPORTS EVENT OCCURRED (B)(6) 2015. THEY WERE INSERTING A PLAIN PACKING STRIP IN WOUND WHEN NURSES SAW RESIDUES AND REMOVED IT RIGHT AFTER. NO HARM DONE TO PATIENT.