FDA Adverse Event Other Summary report: N

MIDAS REX

MDR report key: 99077 · Received June 13, 1997

Report

Report Number
1625507-1997-00002
Event Type
Other
Date Received
June 13, 1997
Date of Event
January 31, 1997
Report Date
April 24, 1997
Manufacturer
MIDAS REX PNEUMATIC TOOLS, INC.
Product Code
HBF
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DURING A CRANIOTOMY PROCEDURE, A MIDAS REX IN LINE OILER'S OIL DRIP RATE SIGHT GLASS CAME OFF AND MISTED THE OR SUITE. STERILE DRAPES WERE PLACED OVER THE WOUND SITE AND STERILE FIELD UNTIL THE MIST CLEARED. THE WOUND WAS IRRIGATED WITH ANTIBIOTICS AND THE PROCEDURE WAS COMPLETED. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THE INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MIDAS REX IN LINE OILER HBF MIDAS REX PNEUMATIC TOOLS, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 41 YR Other INLINE OILER