MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-04 for V MUELLER BE 2847 manufactured by Allegiance Healthcare Corp..
[152485]
A piece of metal equipment that was used to probe the knee broke off inside the pt's knee. Surgeon unable to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018570 |
| MDR Report Key | 272398 |
| Date Received | 2000-04-04 |
| Date of Report | 2000-03-31 |
| Date of Event | 2000-02-11 |
| Date Added to Maude | 2000-04-07 |
| 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 BE 2847 |
| Generic Name | SURGICAL INSTRUMENT (PROBE) |
| Product Code | KAK |
| Date Received | 2000-04-04 |
| Model Number | NA |
| Catalog Number | BE 2847 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 263700 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | JAKO LARYNGEAL PROBE, ANGLED |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | BE2847 |
| Baseline Catalog No | BE2847 |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| 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 | 2000-04-04 |