MAUDE Adverse Event Report: ALPINE BIOMED APS DANTEC; DISPOSABLE SCALP NEEDLE ELECTRODE

Model Number 9013R0313

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/18/2016

Event Type  malfunction  

Event Description

Customer reported separation of scalp needle (pn 9013r0313) while in use, leaving the needle cannula still inserted in the patient's head.

• Brand Name: DANTEC
• Type of Device: DISPOSABLE SCALP NEEDLE ELECTRODE
• Manufacturer (Section D): ALPINE BIOMED APS; tonsbakken 16-18; dk-2740; skovlunde, DK-27 40; DA DK-2740
• Manufacturer (Section G): SP MEDICAL SP. Z.O.O; ui. ceramiczna 2; pl-98 220 zdunska wola; PL-98 220; PL PL-98 220
• Manufacturer Contact: michael galvin ; ida business park; gort; co. galway, ; EI
• MDR Report Key: 5497817
• MDR Text Key: 40597223
• Report Number: 3004827015-2016-00003
• Device Sequence Number: 1
• Product Code: GXZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K932059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 9013R0313
• Device Catalogue Number: 9031R0313
• Device Lot Number: 60552
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1