MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for GALAXY G3 XSFT 3MM X 4CM GLX120304 manufactured by Medos International Sarl.
| Report Number | 3008114965-2020-00065 |
| MDR Report Key | 9904332 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-04-02 |
| Device Manufacturer Date | 2018-10-19 |
| Date Added to Maude | 2020-03-31 |
| 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. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. (FREMONT) |
| Manufacturer Street | 47709 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GALAXY G3 XSFT 3MM X 4CM |
| Generic Name | NEUROVASCULAR EMBOLIZATION DEVICE |
| Product Code | KRD |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-04-02 |
| Model Number | GLX120304 |
| Catalog Number | GLX120304 |
| Lot Number | L13942 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE NEUCHATEL CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |