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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES, INC. STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK ORTHOPEDIC TRAY Back to Search Results
Catalog Number CMPJ08211A
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 04/27/2021
Event Type  Malfunction  
Event Description

Cut in sterile table cover. Fda safety report id# (b)(4).

 
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Brand NameSTERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
northfield IL 60093
MDR Report Key11789897
MDR Text Key249685660
Report NumberMW5101219
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCMPJ08211A
Device LOT Number20HB0550
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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