MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for CONMED QUICK TIP INJECTION NEEDLE 6-19-230 manufactured by Conmed Endoscopic Technologies.
[181720929]
Sclerotherapy needle malfunction needle would not advance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093331 |
| MDR Report Key | 9763823 |
| Date Received | 2020-02-26 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| 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 | 3 |
| Brand Name | CONMED QUICK TIP INJECTION NEEDLE |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION DISPOSABLE |
| Product Code | GAA |
| Date Received | 2020-02-26 |
| Model Number | 6-19-230 |
| Lot Number | G1918755 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED ENDOSCOPIC TECHNOLOGIES |
| Manufacturer Address | UTICA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |