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Adverse Event Report

CONMED, CORP. ELECTROCAUTERY PENCIL   back to search results
Catalog Number 130307
Patient Outcome  Other;
Event Description

Pencil activated by itself. While lying on pt's abdomen. Small burn approx 1/2" x 1/4".

 
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Type of DeviceELECTROCAUTERY PENCIL
Baseline Brand NameCONMED ELECTROSURGICAL ACTIVE INSTRUMENTS
Baseline Generic NameELECTROSURGICAL PENCIL
Baseline Catalogue Number130307
Baseline Device FamilyPENCILS
Baseline Device 510(K) NumberK791137
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed07/24/1979
Manufacturer (Section D)
CONMED, CORP.
310 broad st.
utica NY 13501 1203
Device Event Key138440
MDR Report Key141907
Event Key133295
Report NumberMW1012751
Device Sequence Number1
Product CodeGEI
Report Source Voluntary
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number130307
Device LOT NumberJ97408
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 01/06/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1,BOVIE FORCE FX,

Database last updated on January 30, 2009

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