MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-22 for DUALOK BREAST LESION LOCALIZATION WIRE LW0107 manufactured by Bard Peripheral Vascular, Inc..
[117957877]
No medical records or no medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[117957878]
It was reported that during an ultrasound-guided breast biopsy into normal tissue, the device allegedly failed to deploy and was difficult to remove from the patient. A tear in the patient's tissue occurred as a result of the removal of the device. It was further reported that a planned secondary intervention was performed and another device was used to complete the biopsy. The patient is stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-01528 |
| MDR Report Key | 7807552 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-22 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2018-04-26 |
| Date Added to Maude | 2018-08-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 LOCALIZATION WIRE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-08-03 |
| Catalog Number | LW0107 |
| Lot Number | RECR0358 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-08-22 |