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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTIRES - MUNDELEIN MEDLINE NEEDLE COUNTER 40CT, FOAM BLOCK/MAGNET NEEDLE, SUTURING, DISPOSABLE

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MEDLINE INDUSTIRES - MUNDELEIN MEDLINE NEEDLE COUNTER 40CT, FOAM BLOCK/MAGNET NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Lot Number 67019054505
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 10/17/2019
Event Type  malfunction  
Event Description
Sterile pack opened for blepharoplasty, long black hair found on needle block. Fda safety report id# (b)(4).
 
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Brand NameMEDLINE NEEDLE COUNTER 40CT, FOAM BLOCK/MAGNET
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
MEDLINE INDUSTIRES - MUNDELEIN
MDR Report Key9213918
MDR Text Key163167764
Report NumberMW5090495
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number67019054505
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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