CAST AND BANDAGE PROTECTOR
Received Aug 6, 2014 · Event occurred Jul 1, 2014
Report 1417592-2014-00076 · MDR key 4006329
Device
Product problems
- Moisture or Humidity Problem
Patient
65 YR
- No Code Available
Narrative
Description of Event or Problem
THE DRESSING BECAME WET WHILE SHOWERING AND THE APLIGRAF WAS REPLACED.
Additional Manufacturer Narrative
APLIGRAF HAD BEEN APPLIED TO A LEFT FOOT WOUND ONE MONTH PRIOR TO THE INCIDENT. LAST MONTH WHILE SHOWERING, THE END USER STATED HE FELT WATER INSIDE THE PROTECTOR. HIS DRESSING BECAME WET AND THE APLIGRAF ON HIS FOOT HAD TO BE REAPPLIED. THE PROTECTOR WAS NOT RETURNED TO USE FOR EVAL. IT IS NOT KNOWN IF IT WAS APPLIED CORRECTLY OR IF THERE WAS ANY DAMAGE TO THE PROTECTOR PRIOR TO OR DURING USE. A ROOT CAUSE HAS NOT BEEN DETERMINED. WE HAVE NOT CONFIRMED THAT A DEFECT EXISTED BUT IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED.