MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for DANTEC 9013R0313 9031R0313 manufactured by Alpine Biomed Aps.
[40597223]
Customer reported separation of scalp needle (pn 9013r0313) while in use, leaving the needle cannula still inserted in the patient's head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004827015-2016-00003 |
| MDR Report Key | 5497817 |
| Date Received | 2016-03-14 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-02-18 |
| Device Manufacturer Date | 2015-05-11 |
| Date Added to Maude | 2016-03-14 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | CO. GALWAY, |
| Manufacturer Country | EI |
| Manufacturer G1 | SP MEDICAL SP. Z.O.O |
| Manufacturer Street | UI. CERAMICZNA 2 PL-98 220 ZDUNSKA WOLA |
| Manufacturer City | PL-98220 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-98 220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DANTEC |
| Generic Name | DISPOSABLE SCALP NEEDLE ELECTRODE |
| Product Code | GXZ |
| Date Received | 2016-03-14 |
| Model Number | 9013R0313 |
| Catalog Number | 9031R0313 |
| Lot Number | 60552 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPINE BIOMED APS |
| Manufacturer Address | TONSBAKKEN 16-18 DK-2740 SKOVLUNDE, DK-2740 DA DK-2740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-14 |