PORTEX * 3717C-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-07 for PORTEX * 3717C-20 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[19195842] Spinal anesthesia procedure was performed by anesthesiologist, who stated that there was good cerebral spinal fluid return, but the effects were slight for motor nerve block and absent for sensory nerve effects. Deepened anesthesia was then administered. There were no complications and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3636485
MDR Report Key3636485
Date Received2014-02-07
Date of Report2014-02-07
Date of Event2014-02-05
Report Date2014-02-07
Date Added to Maude2014-02-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePORTEX
Generic NameANESTHESIA KIT SPINAL
Product CodeOFU
Date Received2014-02-07
Model Number*
Catalog Number3717C-20
Lot Number2618245
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address10 BOWMAN DR. KEENE NH 03431 US 03431

Device Sequence Number: 2

Brand Name*
Generic Name*
Product Code---
Date Received2014-02-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Age*
Device Sequence No2
Device Event Key0
Manufacturer*
Manufacturer Address* * * * *

Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-07
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