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

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Device Dislodged or Dislocated (2923); Material Too Soft/Flexible (4007)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

Arms tucked at side of or table.Table tilted to 30 degrees.Dependent arm became dislodged causing the patient to slide towards edge of table.It was identified the medline disposable draw sheet was too short to maintain tucked arms and the material was found to have a slippery surface whereas predicate sheets had a tagrip surface.Vendor representative reported to parent company for investigation and follow up.No further report received at this time.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 11759716
• MDR Text Key: 248446982
• Report Number: 11759716
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 04/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1