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 |