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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN EXTREMITY PACK-LF ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES - MUNDELEIN EXTREMITY PACK-LF ORTHOPEDIC TRAY Back to Search Results
Catalog Number CMPJ08210A
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 01/12/2021
Event Type  malfunction  
Event Description
A small hair was found inside the pack during opening for a procedure. The pack was taken off the table and a new one was opened. Fda safety report id# (b)(4).
 
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Brand NameEXTREMITY PACK-LF
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES - MUNDELEIN
northfield IL 60093
MDR Report Key11385111
MDR Text Key234071065
Report NumberMW5099660
Device Sequence Number1
Product Code OJH
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 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberCMPJ08210A
Device Lot Number20GBH239
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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