MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. COMFORT GLIDE LT; GENERAL SURGERY TRAY

Model Number MSC600LT

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Injury (2348)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

While trying to transfer a patient from a gurney to procedure table on the inflated transfer sheet the seams tore at the handle and the sheet deflated and became inoperable.This malfunction caused a push/pull injury to a staff member.

• Brand Name: COMFORT GLIDE LT
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8955499
• MDR Text Key: 156288863
• Report Number: 8955499
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MSC600LT
• Device Catalogue Number: MSC600LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Date Report to Manufacturer: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1