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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ04385U
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 10/26/2020
Event Type  Malfunction  
Event Description

Back table pack opened and found to have concerns with mold in the folds of the pack.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key11633767
MDR Text Key244441318
Report Number11633767
Device Sequence Number1
Product Code OJH
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 03/25/2021,03/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDYNJ04385U
Device Catalogue NumberDYNJ04385U
Device LOT Number20EKB413
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Event Location No Information
Date Report TO Manufacturer04/08/2021
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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