WARMER DRAPE
Received Feb 6, 2018
Report 8043817-2018-00004 · MDR key 7246201
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300Lot number
D172079
Product problems
- Hole In Material
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 4800 PIECES THAT WERE MANUFACTURED FROM 7/26/2017 TO 7/27/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DHR, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE CUSTOMER IS REPORTING THAT THEY FOUND A HOLE IN A DRAPE. NO INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.