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

Model Number	DYNJ47948B
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: MAJOR ORTHO PACK
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8000226
• Report Number: 8000226
• Device Sequence Number: 13503648
• Product Code: OJH
• UDI-Device Identifier: 10889942650231
• UDI-Public: (01)10889942650231
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/12/2018
• Report Date (Section F): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ47948B
• Device Catalogue Number: DYNJ47948B
• Device Lot Number: 18HBK660
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 138
• Date Report Sent to FDA: 10/12/2018