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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. -SPT BASIC ORTHO TRAY ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ49369
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 05/23/2021
Event Type  Malfunction  
Event Description

A dark hair was found within a sterile medline basic ortho tray. Fda safety report id # (b)(4).

 
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Brand NameBASIC ORTHO TRAY
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC. -SPT
MDR Report Key11885292
MDR Text Key253491059
Report NumberMW5101546
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2021
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 Number21CBE245
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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