MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-11-23 for DUALOCK BREAST LOCALIZATION WIRE LW0077 manufactured by Bard Peripheral Vascular, Inc..
[31966399]
No hospital/medical records or 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 will not be 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
[31966400]
It was reported that during a breast localization wire procedure, the wire was deployed into the breast but did not expand into its normal configuration. The hcp decided to send the patient to another facility to perform the procedure after the wire failed to expand in the breast. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[35369407]
After further clinical review, this event was reassessed and determined to be not mdr reportable. Although, this event is not mdr reportable, an initial mdr has already been submitted; therefore, this supplemental report is being submitted to document the change in reportability and additional product details.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-01911 |
| MDR Report Key | 5244726 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-11-23 |
| Date of Report | 2015-10-28 |
| Date of Event | 2015-10-27 |
| Date Mfgr Received | 2015-12-14 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2015-11-23 |
| 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 WEST 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 | DUALOCK BREAST LOCALIZATION WIRE |
| Generic Name | BREAST LOCALIZATION WIRE |
| Product Code | GDF |
| Date Received | 2015-11-23 |
| Catalog Number | LW0077 |
| Lot Number | REYH2169 |
| Device Expiration Date | 2017-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-23 |