DENTEK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-19 for DENTEK * manufactured by *.

Event Text Entries

[17887622] Family member purchased plastic bag of easy angle floss picks manufactured by: dentek. I only picked up the plastic bag to move it. When i did this, the razor sharp end of one of the floss picks punctured the bag and my finger to the point of bleeding. I was sure i was stuck by a needle. My injury was very minor and stopped bleeding soon without medical help. I am very surprised that someone would make and sell a product like this. Looking at the ends of these floss picks, it is obvious that they can stick the unwarned person, like myself, who was only picking up the bag to move.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1040464
MDR Report Key762884
Date Received2006-09-20
Date of Report2006-09-19
Date of Event2006-09-19
Date Added to Maude2006-09-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENTEK
Generic NameEASY ANGLE FLOSS PICKS
Product CodeJET
Date Received2006-09-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key750783
Manufacturer*
Manufacturer Address* MARYSVILLE TN 37801 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-09-20

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