OMRIX PRESSURE REGULATOR UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-27 for OMRIX PRESSURE REGULATOR UNK manufactured by Omrix Biopharmaceuticals Ltd..

Event Text Entries

[18525805] This was a spontaneous report from a surgeon via a sales representative and concerns a (b)(6) female from the united states: (b)(4). Initial information was processed with additional information received on (b)(6) 2012. The patient's height, weight and medical history were not reported. The patient was treated with evicel (human clottable protein/human thrombin, solution, topical) sprayed via omrix pressure regulator for hemostasis after a laparoscopic total hysterectomy (date of use and dosage unspecified). The surgeon used evicel at a predefined pressure according to instructions for use "ifu" at a 4-6 centimeter distance (exact pressure numbers not reported). Concomitant medications were not reported. The sales representative initially reported that during a laparoscopic hysterectomy the patient went into defibrillation and died. Upon follow-up, the surgeon reported there was oozing bleeding at the vaginal cuff after the hysterectomy. About 10-15 minutes after the evicel application, when the surgery was almost completed and the skin wound was already being closed, the anesthesiologist alerted the surgeon the patient went into cardiac arrest. The surgeon reported that he did not think there was an air embolism and cause of death was unknown. A pathology report was expected. The action taken with human clottable protein/human thrombin was not applicable. The patient died from cardiac arrest on an unspecified date. This report was serious (death) and reportable (death and serious injury). (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003183625-2012-01005
MDR Report Key2854938
Report Source05
Date Received2012-11-27
Date of Report2012-11-13
Date Mfgr Received2012-11-13
Date Added to Maude2012-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer StreetLICENSE #1603, MDA BLOOD BANK SHEBA HOSPITAL
Manufacturer CityRAMAT GAN 52621
Manufacturer CountryIS
Manufacturer Postal52621
Manufacturer Phone2153257722
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOMRIX PRESSURE REGULATOR
Generic NameOTHER
Product CodeBXX
Date Received2012-11-27
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOMRIX BIOPHARMACEUTICALS LTD.
Manufacturer AddressTEL HASHOMER


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2012-11-27

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