MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-12 for FHC STERILE DZAP ARRAY INSERTION ELECTRODE FC2001 manufactured by Fhc, Inc..
| Report Number | 3002250546-2020-00001 |
| MDR Report Key | 9699816 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-12 |
| 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 | MS. KELLY MOEYKENS |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN, ME |
| Manufacturer Country | US |
| Manufacturer Phone | 6665651219 |
| Manufacturer G1 | FHC, INC. |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN, ME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FHC STERILE DZAP ARRAY INSERTION ELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2020-02-12 |
| Model Number | FC2001 |
| Catalog Number | FC2001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC, INC. |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN, ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |