MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-06 for GENICON ALI-GATOR 360-010-001 manufactured by Genicon, Inc..
| Report Number | 3002590791-2020-00002 |
| MDR Report Key | 9803325 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2017-12-11 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2020-03-06 |
| 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 | JOHN BEASLEY |
| Manufacturer Street | 257 GARNET GARDEN STREET |
| Manufacturer City | HENDERSON, NV |
| Manufacturer Country | US |
| Manufacturer Phone | 8895168 |
| Manufacturer G1 | GENICON, INC. |
| Manufacturer Street | 6869 STAPOINT CT. SUITE 114 |
| Manufacturer City | WINTER PARK, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENICON ALI-GATOR |
| Generic Name | APPLIER, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2018-01-18 |
| Model Number | 360-010-001 |
| Lot Number | I8251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENICON, INC. |
| Manufacturer Address | 6869 STAPOINT CT SUITE 114 WINTER PARK, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |