CAST PROTECTOR
Received Jun 17, 2013 · Event occurred May 14, 2013
Report 1417592-2013-00053 · MDR key 3188065
Device
Product problems
- Device Operates Differently Than Expected
Patient
UNK
- No Information
Narrative
Description of Event or Problem
WHILE USING THE CAST PROTECTOR, THE CAST BECAME WET AND HAD TO BE REPLACED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT WHILE USING THE DEVICE, THE CAST BECAME WET AND THE CAST HAD TO BE REPLACED. THE CAST PROTECTOR WAS RETURNED FOR EVALUATION. THERE WERE NO RIPS, DEFECTS, TEARS OR SEALING ISSUES OF THE MATERIAL. THE ELASTIC OPENING DID NOT DISPLAY ANY SIGNS OF PERMANENT DEFORMATION OR BREAKDOWN. IT IS NOT KNOWN IF THE CAST PROTECTOR WAS SIZED CORRECTLY FOR THE END USER OR IF IT HAD BEEN APPLIED CORRECTLY PRIOR TO USE. THERE WAS NO INDICATION THE INCIDENT WAS CAUSED BY A MANUFACTURING DEFECT. A ROOT CAUSE HAS NOT BEEN CONFIRMED. DUE TO THE NEED FOR THE CAST TO BE REPLACED, THIS MEDWATCH IS BEING FILED.