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Adverse Event Report

CONMED CORP CONMED ESU HANDPIECE CAT # 130307 HAND CONTROL PENCIL LOT # J97070   back to search results
Catalog Number 130307
Event Date 05/12/1997
Patient Outcome  Other;
Event Description

During a procedure to excise the fat pad from the inner surface of the left lower eyelid, a spark from the cautery ignited the left upper eyelashes. Nasal o2 was in use under the opthaldrape during the procedure. Spoke with doctor, on 5/14/97. There were no adverse effects from the incident, and no further action or treatment was required.

 
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Brand NameCONMED ESU HANDPIECE CAT # 130307
Type of DeviceHAND CONTROL PENCIL LOT # J97070
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CONMED CORP
1435-j henry brennan dr
el paso TX 79936
Manufacturer (Section D)
CONMED CORP.
310 broad st.
utica NY 13501
Device Event Key108871
MDR Report Key110856
Event Key104230
Report Number110856
Device Sequence Number1
Product CodeGEI
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/12/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number130307
Device LOT NumberJ97070
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/12/1997
Event Location AMBULATORY SURGICAL Facility
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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