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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. MAJOR ORTHO PACK ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ47948B
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 10/03/2018
Event Type  malfunction  
Event Description
Cautery pencil from major ortho pack with lot no 18hbk660 signaled "in use" even when button was not pressed. Cautery pencil unplugged from electrical unit. New pencil from or stock passed to field. Alleged cut/burn to patient's arm.
 
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Brand NameMAJOR ORTHO PACK
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1204 townline rd
1 medline place
mundelein IL 60060
MDR Report Key8000226
MDR Text Key124952998
Report Number8000226
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDYNJ47948B
Device Catalogue NumberDYNJ47948B
Device Lot Number18HBK660
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/12/2018
Event Location Hospital
Date Report to Manufacturer10/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/24/2018 Patient Sequence Number: 1
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