MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for DUALOK BREAST LESION LOCALIZATIONS WIRE LW0107 manufactured by Bard Peripheral Vascular, Inc..
[141023832]
This report summarizes 1 malfunction event involving 2 devices on the same patient. A review of the event indicated that model lw0107 breast localization wire experienced both difficulty to advance and difficulty to remove on both devices. This was received from one source. The event involved a patient with no reported injury. The patient is female, and age and weight were not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-00229 |
| MDR Report Key | 8485527 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-07-25 |
| Date Mfgr Received | 2019-06-30 |
| Date Added to Maude | 2019-04-04 |
| 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 | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUALOK BREAST LESION LOCALIZATIONS WIRE |
| Generic Name | BREAST LOCALIZATION WIRES |
| Product Code | GDF |
| Date Received | 2019-04-04 |
| Model Number | LW0107 |
| Catalog Number | LW0107 |
| Lot Number | RECS1578 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |