FDA Adverse Event
Injury
Summary report: N
MTS ANTI-IGG GEL CARD
MDR report key: 2070927
·
Received April 27, 2011
Report
- Report Number
- 1056600-2011-00038
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- April 2, 2011
- Report Date
- April 27, 2011
- Manufacturer
- MICROTYPING SYSTEMS
- Product Code
- KSZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
OCD MEDICAL HAS ASSESSED THIS EVENT AS A SERIOUS INJURY. INCIDENT OCCURRED WHILE USER WAS OPENING GEL CARD. (B)(4).
Description of Event or Problem · 1
CUSTOMER STATED THAT DURING THE REMOVAL OF THE FOIL ON THE MTS IGG GEL CARD THAT A "DROP" OF THE FLUID SPLASHED INTO HER EYE. AFTER THE INCIDENT OCCURRED, TECH FLUSHED HER EYE WITH FLUID USING THE EYE WASH STATION. THERE WAS NO IRRITATION, NO REDNESS NOR ANY OTHER FORM OF IRRITATION. TECH WAS IN TOUCH WITH HER EMPLOYEE HEALTH SERVICE AND NO MEDICAL TREATMENT WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MTS ANTI-IGG GEL CARD | ANTIBODY SCREENING REAGENT | KSZ | MICROTYPING SYSTEMS | 120110001-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |