MalfunctionFYH
DELTA-SPLINT SYNTH RL 4"X15FT
Received Oct 10, 2003 · Event occurred Sep 10, 2003
Report 1818910-2003-00668 · MDR key 488793
Device
Generic name
Casting
Manufacturer
Depuy-north Brunswick Casting Products Div.Model number
NACatalog number
51143
Lot number
UNK
Product problems
- Replace
- Other (for use when an appropriate device code cannot be identified)
Patient
NA
- Unknown (for use when the patient's condition is not known)
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
SEVERAL PEOPLE GOT A LONGUETTE DELTA SPLINT ON THE LOWER LEG IN U-FORM. THEY ALL HAD MACERATIONS AT THEIR HEELS AND BUBBLES ON THE SKIN OR EVEN OPEN WOUNDS. THE PTS WERE TREATED WITH PRODUCTS FROM ANOTHER SUPPLIER BEFORE, WITH THESE THEY HAD NO PROBLEMS. IT WAS REPORTED THAT THE DELTA SPLIT IS VERY SLOW DRYING ALTHOUGH IT WAS EXPRESSED IN A TOWEL.
Remedial action
- Other