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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/128CZ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Paralysis (1997)
Event Date 03/03/2018
Event Type  Injury  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received indicating that three days following placement of a smiths medical portex® epidural minipack a hematoma formed. Subsequently, lower extremity paralysis occurred requiring that a laminectomy be performed under general anesthesia. It was noted that the patient was hospitalized due to a lobectomy due to lung cancer. No further adverse effects were reported.
 
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Brand NamePORTEX® EPIDURAL MINIPACKS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL CZECH REPUBLIC A. S.
olomouck[?] 306,
hranice 1
mesto, hranice 753 0 1
EZ 753 01
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key7706344
MDR Text Key114573270
Report Number3012307300-2018-02893
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeRS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial
Report Date 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number100/391/128CZ
Device Lot Number3470048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2018 Patient Sequence Number: 1
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