MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-12-13 for POLYMEDCO SEDCHEK (ABNORMAL) ESR2CT manufactured by .
[769281]
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.
Patient Sequence No: 1, Text Type: D, B5
[7932552]
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. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2007-00003 |
| MDR Report Key | 966110 |
| Report Source | 07 |
| Date Received | 2007-12-13 |
| Date of Report | 2007-12-12 |
| Date of Event | 2007-11-09 |
| Date Mfgr Received | 2007-11-12 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-04-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH PLATT |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981285 |
| Manufacturer G1 | POLYMEDCO |
| Manufacturer Street | 510 FERNACE DOCR RD |
| Manufacturer City | CORTLANDT MANOR NY 10567 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10567 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYMEDCO SEDCHEK (ABNORMAL) |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJT |
| Date Received | 2007-12-13 |
| Model Number | NA |
| Catalog Number | ESR2CT |
| Lot Number | 110-0907-1A |
| ID Number | NA |
| Device Expiration Date | 2008-12-06 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 972364 |
| Manufacturer Address | 510 FERNACE DOCK RD CORTLANDT MANOR NY 10567 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-12-13 |