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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BASIC ORTHO PACK ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES, INC. BASIC ORTHO PACK ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ49369
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Date 02/19/2021
Event Type  Malfunction  
Event Description

Medline basic ortho tray contained only 4 of the indicated 5 sponges. Fda safety report id # (b)(4).

 
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Brand NameBASIC ORTHO PACK
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
IL 60093
MDR Report Key11372389
MDR Text Key233526158
Report NumberMW5099592
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJ49369
Device Catalogue NumberDYNJ49369
Device LOT Number20EBL449
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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