inforMED
InjuryFMP

KERRAPRO

Received Mar 29, 2019 · Event occurred Jun 14, 2017

Report 3004051837-2019-00003 · MDR key 8463663

Device

Generic name

Kerrapro Heel

Model number

KPRO30

Catalog number

KPRO30

Lot number

UNKNOWN

Product problems

  • Labelling, Instructions for Use or Training Problem
  • Inadequate or Insufficient Training
  • Labelling, Instructions for Use or Training Problem
  • Inadequate or Insufficient Training

Patient

Not reported

  • Pressure Sore/Ulcer
  • Pressure Sore/Ulcer

Narrative

Description of Event or Problem

THE WARD MANAGER AND MATRON IDENTIFIED SUSPECTED DEEP TISSUE INJURIES HAD POSSIBLY INCREASED IN THE LAST MONTH. THEY SUGGESTED THE ONLY CHANGE THAT HAD BEEN MADE WAS THE INCREASED USE OF KERRAPRO AND BOTH PATIENTS WERE DOCUMENTED AS HAVING KERRAPRO HEELS IN PLACE AT TIME OF PRESSURE DAMAGE BEING IDENTIFIED. THE WARD HAVE IDENTIFIED SDTI TO HEELS PRIOR TO THIS WHERE KERRAPRO IS NOT IN USE, HOWEVER THIS WAS A THEORY HIGHLIGHTED BY THE WARD MANAGER AND MATRON WHEN HOSPITAL ACQUIRED PRESSURE DAMAGE WAS IDENTIFIED IN QUICK SUCCESSION. USE OF THE NORMAL OFFLOADING FOAM BOOTS HAD BEEN DISCONTINUED BY THE WARD AND AN INCREASE IN USE OF KERRAPRO HAS BEEN IDENTIFIED OVER THE LAST MONTH. DISCUSSIONS OF APPROPRIATE USE OF THE PRODUCT WITH STAFF ON THE WARD AND OTHER WARDS IDENTIFIED THAT STAFF ON THE WARD WHERE THE INCIDENT OCCURED WERE NOT AS CONFIDENT IN THE PRODUCTS USE OR WHEN TO REMOVE/CHECK DEVICE PLACEMENT. WARD STAFF STATED THE ISSUE THEY IDENTIFIED WAS MACERATION OF SKIN, WHICH MAY BE SUGGESTIVE OF NOT REMOVING AS APPROPRIATE. AS STAFF ON THIS WARD WERE UNCLEAR OF WHEN THEY WOULD CHECK THE DEVICE DURING THE DAY IT MAY SUGGEST PRESSURE DAMAGE WAS CAUSED BY SLIPPAGE OF THE DEVICE AND PRESSURE OCCURRING ON THIS AREA. NO OTHER WARDS HAVE REPORTED SIMILAR CONCERNS. CURRENTLY KERRAPRO IS STILL BEING USED; HOWEVER, REMOVED FROM THE WARD.