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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH ORTHOPEDIC TRAY

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CARDINAL HEALTH 200, LLC CARDINAL HEALTH ORTHOPEDIC TRAY Back to Search Results
Model Number SOP56TK80G
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 12/19/2017
Event Type  Malfunction  
Event Description

Lower extremity pack was opened, a long black hair discovered inside of the sterile pack. Entire sterile field was discarded of and new supplies were opened before patient entered an or suite.

 
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Brand NameCARDINAL HEALTH
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
785 fort mill hwy.
fort mill SC 29707
MDR Report Key7177971
MDR Text Key96829543
Report Number7177971
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date06/01/2019
Device MODEL NumberSOP56TK80G
Device Catalogue NumberSOP56TK80G
Device LOT Number801755
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2017
Device Age2 mo
Event Location Hospital
Date Report TO Manufacturer12/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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