MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-02 for V. MUELLER RH-750 * manufactured by V-mueller Baxter Healthcare.
[52496]
At the completion of the case, surgeon noticed that a small piece of the elevator freer was missing. It is unknown whether it was retained in the pt or lost elsewhere.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010811 |
| MDR Report Key | 81122 |
| Date Received | 1997-04-02 |
| Date of Report | 1997-03-10 |
| Date of Event | 1997-02-19 |
| Date Added to Maude | 1997-04-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V. MUELLER |
| Generic Name | ELEVATOR FREER |
| Product Code | GEG |
| Date Received | 1997-04-02 |
| Model Number | RH-750 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 80562 |
| Manufacturer | V-MUELLER BAXTER HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Baseline Brand Name | FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5" |
| Baseline Generic Name | SEPTUM ELEVATOR |
| Baseline Model No | RH750 |
| Baseline Catalog No | RH750 |
| Baseline ID | NA |
| Baseline Device Family | ELEVATOR |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-02 |