FDA Adverse Event Injury Summary report: N

NEEDLE ELECTRODE

MDR report key: 4819 · Received February 10, 1993

Report

Report Number: 4819
Event Type: Injury
Date Received: February 10, 1993
Report Date: February 10, 1993
Manufacturer: EDWARD WECK, INC.
Product Code: GXZ
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ACCIDENTAL BURN ON RIGHT UPPER NARES BY BASE OF ELECTRODE WHEN USED WITH CONMED SWITCH PENCIL AND VALLEY LAB GENERATORINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEEDLE ELECTRODE		GXZ	EDWARD WECK, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention