*
Received Mar 31, 2008
Report MW5006049 · MDR key 1021514
Device
Generic name
Finger Sucking Device
Manufacturer
Medel DevelopmentModel number
*Catalog number
*
Lot number
*
Product problems
- Material Fragmentation
Patient
4 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
MOTHER OF A CHILD CALLED TO REPORT THAT AFTER 10 DAYS USING THE DEVICE, HER CHILD CHEWED IT, AND IT IS UNKNOWN IF THE FRAGMENTED PIECE WAS SWALLOWED OR NOT. SHE STATED THAT HER CHILD NEEDS TO WEAR THIS DEVICE 24 HR/DAY FOR 3-4 WEEKS TO GET THE RESULTS WHICH IS TO HELP HER STOP SUCKING.