MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-04-02 for FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5" RH750 manufactured by Site-1923569-v. Mueller/surgical Group.
[16275229]
At the completion of the septal plasty case, the surgeon noticed that a small piece of the elevator 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 | 1423537-1997-00058 |
| MDR Report Key | 81135 |
| Report Source | 05,06 |
| Date Received | 1997-04-02 |
| Date of Report | 1997-03-10 |
| Date of Event | 1997-02-19 |
| Date Facility Aware | 1997-02-19 |
| Report Date | 1997-03-10 |
| Date Reported to FDA | 1997-04-01 |
| Date Reported to Mfgr | 1997-03-20 |
| Date Mfgr Received | 1997-03-20 |
| Device Manufacturer Date | 1976-03-01 |
| Date Added to Maude | 1997-04-07 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5" |
| Generic Name | SEPTUM ELEVATOR |
| Product Code | GEG |
| Date Received | 1997-04-02 |
| Model Number | RH750 |
| Catalog Number | RH750 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 80562 |
| Manufacturer | SITE-1923569-V. MUELLER/SURGICAL GROUP |
| Manufacturer Address | 5 SUNNEN DRIVE BLDG. K ST. LOUIS MO 63143 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 |