MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-28 for SEDIPLAST SEDIPLAST WESTERGREN ESR SYSTEM S 100 manufactured by Polymedco, Inc..
[16728194]
When using device, blood shot out of top of pipette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2771318 |
| MDR Report Key | 2771318 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-09-28 |
| Date of Event | 2012-09-28 |
| Report Date | 2012-09-28 |
| Date Reported to FDA | 2012-09-28 |
| Date Added to Maude | 2012-10-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDIPLAST |
| Generic Name | TEST, ERYTHROCYTE SEDIMENTATION RATE |
| Product Code | JPH |
| Date Received | 2012-09-28 |
| Model Number | SEDIPLAST WESTERGREN ESR SYSTEM |
| Catalog Number | S 100 |
| Lot Number | 0117283 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Age | 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POLYMEDCO, INC. |
| Manufacturer Address | 510 FURNACE DOCK RD. CORTLANDT MANOR NY 10567 US 10567 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-28 |