FDA Adverse Event
Other
Summary report: N
ACL 1000 & ACL 3000/ACL REAGENTS
MDR report key: 26583
·
Received August 2, 1995
Report
- Report Number
- 1023939-1995-00002
- Event Type
- Other
- Date Received
- August 2, 1995
- Date of Event
- July 12, 1995
- Report Date
- July 31, 1995
- Manufacturer
- INSTRUMENTATION LABORATORIES, INC.
- Product Code
- GKP
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MAINTENANCE MAN WAS USING AN ELECTRIC SAW ON A DRAIN WHEN THE DRAIN EXPLODED. AS A RESULT OF THE EXPLOSION, THE MAINTENANCE MAN'S HAND SUSTAINED CHEMICAL BURNS. PRIOR TO THE INCIDENT, THE INDIVIDUAL WAS DEAF IN ONE EAR & IS CURRENTLY BEING TESTED TO DETERMINE IF HE OBTAINED ADD'L POSSIBLE HEARING LOSS IN HIS OTHER EAR. THE SINK WAS BEING USED TO REMOVE THE WASTE THAT WAS GENERATED FROM THEIR TWO INSTRUMENTS. THE LABORATORY PERSONNEL HAD BEEN RUNNING A STREAM OF WATER INTO THE WASTE LINE TO KEEP THE SODIUM AZIDE FROM BONDING TO THE PIPES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACL 1000 & ACL 3000/ACL REAGENTS | COAGULATION INSTRUMENTATION & REAGENTS | GKP | INSTRUMENTATION LABORATORIES, INC. | 0105 & 0110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |