FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 3218 · Received July 1, 1992

Report

Report Number: 3218
Event Type: Injury
Date Received: July 1, 1992
Date of Event: December 20, 1991
Report Date: January 6, 1992
Manufacturer: HUDSON OXYGEN THERAPY SALES
Product Code: CAT
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

1. FLASH FIRE IN SURGERY WHILE CAUTERY BEING USED ON PROCEDURE.2. IMMEDIATER TREATMENT WITH COLD STERILE SOAKS, ICE TO LIPS, ADMITTED TO HOSPITAL. DISMISSED FROM HOSPITAL ON DECEMBER 25, 1991, TO FOLLOW-UP IN DR. OFFICE.3. 71 DEGREE TEMPERATURE, 50% HUMIDITY.4. SURGICAL DRAPES - KIMBERLY CLARK AND STANDARD TEXTILE, GROUNDING PAD - 3-M SURGICAL, CAUTERY PENCIL - VALLEY, CAUTERY UNIT - VALLEY LABDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN	NASAL CANNULA	CAT	HUDSON OXYGEN THERAPY SALES	1103	1-40150

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention