MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-05-08 for LELOC TUMOR LOCALIZER 8512309 * manufactured by Mri Devices Corp..
[15740387]
Pt was sent to radiologist to perform mr guided wire localization on suspicious lesion on breast. Pt had dense, fibrous breasts. Physician had difficulty placing the wire locator on lesion and it broke. After mr procedure, physician detected broken piece, notified surgeon before biopsy, and piece was surgically removed during the biopsy of the lesion. No permanent damage to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184005-2004-00001 |
| MDR Report Key | 559464 |
| Report Source | 05,06 |
| Date Received | 2004-05-08 |
| Date of Report | 2004-03-26 |
| Date of Event | 2004-03-24 |
| Date Mfgr Received | 2004-03-26 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2004-12-15 |
| 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 | AL ZERNIA, MGR |
| Manufacturer Street | 1515 PARAMOUNT DR |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2625241402 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LELOC TUMOR LOCALIZER |
| Generic Name | WIRE LOCALIZATION NEEDLE |
| Product Code | MIG |
| Date Received | 2004-05-08 |
| Model Number | 8512309 |
| Catalog Number | * |
| Lot Number | 149A/0304/1 |
| ID Number | * |
| Device Expiration Date | 2009-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 549173 |
| Manufacturer | MRI DEVICES CORP. |
| Manufacturer Address | * WAUKESHA WI * US |
| Baseline Brand Name | LELOU TUMOR LOCALIZER |
| Baseline Generic Name | TUMOR LOCALIZER |
| Baseline Model No | 8512309 |
| Baseline Device Family | TUMOR LOCALIZER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K962615 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-08 |