MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SPROTTE NRFIT 121163-30A manufactured by Pajunk Gmbh Medizintechnologie.
| Report Number | 9611612-2019-00027 |
| MDR Report Key | 9143775 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-25 |
| Date Added to Maude | 2019-10-02 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR CHRISTIAN QUASS |
| Manufacturer Street | KARL-HALL-STR. 1 TUTTLINGER STR. 7 |
| Manufacturer City | GEISINGEN, 78187 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78187 |
| Manufacturer G1 | PAJUNK GMBH MEDIZINTECHNOLOGIE |
| Manufacturer Street | KARL-HALL-STR. 1 TUTTLINGER STR. 7 |
| Manufacturer City | GEISINGEN, 78187 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78187 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPROTTE NRFIT |
| Generic Name | NEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT |
| Product Code | BSP |
| Date Received | 2019-10-02 |
| Model Number | 121163-30A |
| Catalog Number | 121163-30A |
| Lot Number | 1294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAJUNK GMBH MEDIZINTECHNOLOGIE |
| Manufacturer Address | KARL-HALL-STR. 1 TUTTLINGER STR. 7 GEISINGEN, 78187 GM 78187 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-02 |