MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-29 for DISPOSABLE SCALP NEEDLE ELECTRODES 9013R0313 manufactured by Alpine Biomed Aps.
[26973095]
Registered internally as a (b)(4)) for investigative purposes. The contract manufacturer sp medical have also been issued a supplier corrective action report (scar) to provide details and results of their investigation into separation of the needles and all resulting corrective and preventative action ((b)(4)) the device history record for this batch was provided by (b)(6) medical and reviewed. In process testing and inspections were reviewed. All samples taken for tests gave acceptable result. No issues were noted. No rework or sort performed on this lot. No ncr's noted for this lot.
Patient Sequence No: 1, Text Type: N, H10
[26973096]
Customer reported finding a broken needle on opening a box of scalp needles and another needle from the same box broke while in the patients head. The needle came apart from the hub during use, leaving the needle still inserted in the patients head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004827015-2015-00001 |
| MDR Report Key | 5109965 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-29 |
| Date of Report | 2015-09-28 |
| Date of Event | 2015-09-11 |
| Date Mfgr Received | 2015-09-12 |
| Device Manufacturer Date | 2015-02-24 |
| Date Added to Maude | 2015-09-29 |
| 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 |
| 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 | GALWAY, |
| Manufacturer Country | EI |
| Manufacturer Phone | 91647451 |
| Manufacturer G1 | SP MEDICAL A/S |
| Manufacturer Street | M 4653 KARISE |
| Manufacturer City | 4653 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 4653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE SCALP NEEDLE ELECTRODES |
| Generic Name | ELECTRODE |
| Product Code | GXZ |
| Date Received | 2015-09-29 |
| Model Number | 9013R0313 |
| Catalog Number | 9013R0313 |
| Lot Number | 60550 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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, DENMARK DK-2740 DA DK-2740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-29 |