MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-21 for ZEITEL INJECTION NEEDLE ART-044 REV. F manufactured by Endocraft Llc.
[15193229]
Tip of zeiterl's injection needle broke off and embedded in patient's laryngeal tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025489 |
| MDR Report Key | 2588489 |
| Date Received | 2012-05-21 |
| Date of Report | 2012-05-21 |
| Date of Event | 2012-05-15 |
| Date Added to Maude | 2012-05-31 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEITEL INJECTION NEEDLE |
| Generic Name | ZEITEL INJECTION NEEDLE |
| Product Code | KAA |
| Date Received | 2012-05-21 |
| Model Number | ART-044 REV. F |
| Lot Number | 71296-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOCRAFT LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-21 |