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

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.

• Brand Name: MAJOR ORTHO PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8000226
• MDR Text Key: 124952998
• Report Number: 8000226
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942650231
• UDI-Public: (01)10889942650231
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ47948B
• Device Catalogue Number: DYNJ47948B
• Device Lot Number: 18HBK660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22995 DA
• Patient Weight: 138