FDA Adverse Event
Injury
Summary report: N
0.8% SURGISCREEN
MDR report key: 1727243
·
Received June 17, 2010
Report
- Report Number
- 2250051-2010-00154
- Event Type
- Injury
- Date Received
- June 17, 2010
- Date of Event
- May 19, 2010
- Report Date
- June 16, 2010
- Manufacturer
- ORTHO CLINICAL DIAGNOSTICS
- Product Code
- KSZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INDIVIDUAL WASHED AND DISINFECTED THE INVOLVED AREA; NO MEDICAL TREATMENT, THERAPY, OR MEDICATION WAS GIVEN TO THE OPERATOR. BROKEN VIAL WAS DUE TO VIAL BEING DROPPED. NO INVESTIGATION PERFORMED. (B) (4)
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A WAREHOUSE OPERATED INADVERTENTLY SPILLED REAGENT RED CELLS ON HER HAND WHILE PICKING UP A BROKEN VIAL. CUSTOMER HAD A PRE-EXISTING CUT ON THE THUMB. CUSTOMER IS NOT CERTAIN WHETHER ANY REAGENT RED CELLS GOT INTO THE CUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% SURGISCREEN | REAGENT RED BLOOD CELLS | KSZ | ORTHO CLINICAL DIAGNOSTICS | 8SS617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |