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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICORE LITE TOUCH LANCETS

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MEDICORE LITE TOUCH LANCETS   Back to Search Results
Catalog Number 202T
Event Date 08/22/2012
Event Type  Malfunction  
Event Description

Lancet needle slips out of plastic base when the removable tip is pulled. Not all lancets in box appear to be defective. One lancet twice daily, top. Dates of use: (b)(6) 2012.

 
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Brand NameLITE TOUCH LANCETS
Type of DeviceLANCETS
Manufacturer (Section F)
MEDICORE
miami FL 33016
Manufacturer (Section D)
MEDICORE
miami FL 33016
Device Event Key2749692
MDR Report Key2718942
Event Key2615538
Report NumberMW5026672
Device Sequence Number2
Product CodeFMK
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 08/23/2012
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received08/23/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number202T
Device LOT Number2110820
OTHER Device ID NumberPRODUCT # 202T
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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