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Adverse Event Report

COHERENT MEDICAL GROUP ULTRAFINE ERBIUM SYSTEM SURGICAL LASERS   back to search results
Catalog Number 0633-734-01
Event Date 03/22/1999
Event Type  Injury   Patient Outcome  Hospitalization; Life Threatening
Event Description

During facial resurfacing treatment with ultrafine laser, the pt experienced cardiac arrest.

 
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Brand NameULTRAFINE ERBIUM SYSTEM
Type of DeviceSURGICAL LASERS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COHERENT MEDICAL GROUP
2400 condensa st
santa clara CA 95051 0901
Manufacturer (Section D)
COHERENT MEDICAL GROUP
2400 condensa st
santa clara CA 95051 0901
Manufacturer (Section G)
LUMENIS, INC.
5302 betsy ross rd,
santa clara CA 95054
Device Event Key213552
MDR Report Key220189
Event Key206610
Report Number2914019-1999-00001
Device Sequence Number1
Product CodeGEX
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/07/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0633-734-01
OTHER Device ID NumberK972347/T971212
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received04/07/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1998
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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