FDA Adverse Event
Other
Summary report: N
POLYMEDCO SEDCHEK (ABNORMAL)
MDR report key: 966110
·
Received December 13, 2007
Report
- Report Number
- 2016706-2007-00003
- Event Type
- Other
- Date Received
- December 13, 2007
- Date of Event
- November 9, 2007
- Report Date
- December 12, 2007
- Product Code
- JJT
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LABELING AND CERTIFICATE OF ANALYSIS INDICATES THAT "EACH DONOR UNIT USED IN PREPARATION OF SED-CHEK 2 HAS BEEN TESTED AND FOUND TO BE NON-REACTIVE FOR ANTIBODIES." THE LABELING STATES THAT "BECAUSE NO TEST METHOD CAN OFFER COMPLETE ASSURANCE OR OTHER INFECTIOUS AGENTS ARE ABSENT, IT IS RECOMMENDED THAT HUMAN BLOOD BASED PRODUCT BE HANDLED WITH THE SAME PRECAUTIONS USED FOR ANY POTENTIALLY BIOHAZARDOUS PTS SPECIMENS."
Description of Event or Problem · 1
A LAB TECH DROPPED THE POLYMEDCO SEDCHEK 2 (ABNORMAL) GLASS VIAL ON THE FLOOR. THE GLASS VIAL BROKE AND THE TECH PICKED UP THE PIECES OF GLASS WITH GLOVES AND IN THE PROCESS, CUT HIS FINGER. NO HOSPITALIZATION WAS NECESSARY. THIS WAS REPORTED TO THE INFECTION CONTROL DEPARTMENT WITHIN THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYMEDCO SEDCHEK (ABNORMAL) | QUALITY CONTROL MATERIAL | JJT | NA | 110-0907-1A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |