MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-02-29 for * manufactured by Clinical Innovations, Llc.
[8032085]
We have contacted the hospital several times, but as of the date of this filing, have not received any further info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722684-2008-00002 |
| MDR Report Key | 1005270 |
| Report Source | 00 |
| Date Received | 2008-02-29 |
| Date Mfgr Received | 2008-02-20 |
| Date Added to Maude | 2008-03-04 |
| 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 | 0 |
| Manufacturer Contact | WM WALLACE |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HGS |
| Date Received | 2008-02-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 973824 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-29 |