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 |