FDA Adverse Event Injury Summary report: N

ORANGE OIL

MDR report key: 2780 · Received February 1, 1993

Report

Report Number
2780
Event Type
Injury
Date Received
February 1, 1993
Date of Event
August 13, 1992
Report Date
October 13, 1992
Manufacturer
LORANN OILS, INC.
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT IN DAY SURGERY UNIT FOR LEFT INGUINAL LERNID REPAIR. ORANGE OIL WIPED INTO INSIDE OF ANESTHESIA MASK TO MAKE SMELL OF MASK MORE PLEASANT TO BREATH FOR PATIENT. UPON COMPLETION OF SURGICAL PROCEDURAL, PARTIAL HICKNESS WOUND WAS NOTED AT MID-BACK( SOME ORANGE OIL NOTED ON BACK BLANKET UNDER PATIENT'S BACK). DERMATOLOGY AND PLASTIC SURGERY WERE CONSULTED. PATIENT ADMITTED FOR WOUND IRRIGATION AND DRESSING APPLICATIONS. ORANGE OIL PRODUCT WAS SENT TO PHARMACY TOXICOLOGY LAB FOR ANALYSIS. VALLEY LAB ELECTROSURGICAL UNIT AND HAMILTON AQUAMATIC BLANKET WARMER WERE ALSO USED DURING THIS SURGICAL PROCEDURE. BOTH OF THESE PIECES OF EQUIPMENT WERE EVALUATED/TESTED BY OPUR BIOMEDICAL EQUIPMENT DEPARTMENT AND WERE FOUND TO BE FUNCTIONING APPROPRIATELYDEVICE NOT 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, OTHER. RESULTS OF EVALUATION: UNANTICIPATED. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ORANGE OIL LORANN OILS, INC.

Patients

Seq Age Sex Outcome Treatment
1 3 YR Required Intervention