MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-12 for OMNI 144-42112 manufactured by Extremity Medical, Llc..
| Report Number | 3007289093-2020-00005 |
| MDR Report Key | 9702479 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-11-22 |
| 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 | MR. BRIAN SMEKAL |
| Manufacturer Street | 300 INTERPACE PARKWAY SUITE 410 |
| Manufacturer City | PARSIPPANY, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 5888980898 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI |
| Generic Name | BONE WASHER |
| Product Code | HTN |
| Date Received | 2020-02-12 |
| Catalog Number | 144-42112 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTREMITY MEDICAL, LLC. |
| Manufacturer Address | 300 INTERPACE PARKWAY SUITE 410 PARSIPPANY, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |