MalfunctionIOY
DONJOY
Received Dec 18, 2002
Report MW1027025 · MDR key 434219
Device
Generic name
Ultra Sling Ii
Manufacturer
D.j. Orthopedics LlcModel number
ULTRASLING II,BLK,SCatalog number
11-0449-2-06000
Lot number
112102
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DONJOY ULTRA SLING II. CO STATES THAT RUBBER BALL PACKAGED WITH SLING CONTAINS NATURAL RUBBER. THERE IS NO LABELING ON PRODUCT LABEL THAT INDICATES THAT RUBBER CONTENTS.