InjuryFYH
DELTA-SPLINT SYNTH RL 4"X15FT
Received Aug 13, 2003 · Event occurred Jul 18, 2003
Report 1818910-2003-00530 · MDR key 477552
Device
Generic name
Casting Products
Manufacturer
Depuy-north Brunswick, Casting Products DivisionModel number
NACatalog number
51143
Lot number
1141
Product problems
- Product Quality Problem
- Unknown (for use when the device problem is not known)
Patient
NA
- Other (for use when an appropriate patient code cannot be identified)
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PATIENT SUFFERED FROM MACERATION 3 DAYS AFTER APPLICATION OF THE DELTA SPLINT TONGUETTE. THE USER NOTICED THAT THE HUMIDITY USED TO ACTIVATE THE LONGUETTE STILL WAS NOT EVAPORATED ON THE 3RD DAY, SO THAT THE LONGUETTE STILL WAS VERY WET.
Remedial action
- Other