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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY Back to Search Results
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.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl.
mundelein IL 60060
MDR Report Key11759716
MDR Text Key248446982
Report Number11759716
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2021
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 FDA04/26/2021
Event Location Hospital
Date Report TO Manufacturer05/03/2021
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? No
Type of Device Usage Unkown

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