MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for RNA MEDICAL QC 253 BULKSAA4008 manufactured by Bionostics, Inc..
[66286808]
In (b)(6), assuming that it was in (b)(6), one of the customers injured himself while opening one vial of qc 253. We received the report from a sales assistant quality management from (b)(6). She did not receive any additional information from the person injured despite request for additional information. We the manufacturer, received the report on 01/17/2017. Diagnosis or reason for use: unk- (b)(6) injured himself while breaking the vial open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067554 |
| MDR Report Key | 6290026 |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-17 |
| Date Added to Maude | 2017-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RNA MEDICAL QC 253 |
| Generic Name | QC 253 |
| Product Code | JJS |
| Date Received | 2017-01-27 |
| Model Number | QC 253 |
| Catalog Number | BULKSAA4008 |
| Lot Number | OXY60415 |
| Device Expiration Date | 2017-09-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONOSTICS, INC. |
| Manufacturer Address | DEVENS MA 01434 US 01434 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-27 |