MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-11-25 for R & D SEDRITE PLUS SED-1U manufactured by R & D Systems.
[19719299]
A laboratory technician received some projection in his eye while proceeding to the analysis.
Patient Sequence No: 1, Text Type: D, B5
[19975542]
Product not returned to manufacturer by end customer. This incident is undergoing review to ensure that instructions are clear and there are no other reasons for a product modification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182501-2014-00001 |
| MDR Report Key | 4304535 |
| Report Source | 01 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2014-10-28 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-12-12 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHON HEINONEN |
| Manufacturer Street | 614 MCKINLEY PLACE NE |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal | 55413 |
| Manufacturer Phone | 6128514819 |
| Manufacturer Street | 2001 KENNEDY STREET |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55413 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R & D SEDRITE PLUS |
| Generic Name | UNLABELED 6ML VIAL ESR2 LEVEL 1 |
| Product Code | JPK |
| Date Received | 2014-11-25 |
| Model Number | NA |
| Catalog Number | SED-1U |
| Lot Number | SR104E-1 |
| ID Number | NA |
| Device Expiration Date | 2015-01-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R & D SYSTEMS |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-25 |