MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-07-03 for GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE UNKNOWN manufactured by Grace Medical, Inc..
| Report Number | 1000022662-2019-00010 |
| MDR Report Key | 8759201 |
| Report Source | OTHER |
| Date Received | 2019-07-03 |
| Date of Report | 2019-07-03 |
| Date Mfgr Received | 2019-06-08 |
| Date Added to Maude | 2019-07-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARLYN REYNOLDS |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal | 381334104 |
| Manufacturer Phone | 9013860990 |
| Manufacturer G1 | GRACE MEDICAL, INC. |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 381334104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2019-07-03 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL, INC. |
| Manufacturer Address | 8500 WOLF LAKE DRIVE SUITE 110 MEMPHIS TN 381334104 US 381334104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-03 |