MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-28 for HA LITE TOTAL 630 manufactured by Grace Medical.
[2221074]
Report was received that the prosthesis was extruding. Prosthesis implanted (b)(6) 2011, revision surgery performed on (b)(6) 2011. Physician reported that "it was not a product defect. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057421-2011-00002 |
| MDR Report Key | 2326221 |
| Report Source | 05,07 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-09-30 |
| Date of Event | 2011-09-27 |
| Date Mfgr Received | 2011-09-30 |
| Date Added to Maude | 2011-11-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BILL GRAHAM, MANAGER |
| Manufacturer Street | 8500 WOLF LAKE DR., STE. 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013860990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HA LITE TOTAL |
| Generic Name | TOTAL OSSICULAR REPLACEMENT PROSTHESIS |
| Product Code | ETA |
| Date Received | 2011-10-28 |
| Catalog Number | 630 |
| Lot Number | 17625 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-28 |