MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-23 for ANGIOTECH manufactured by Medical Device Technologies, Inc..
[3294066]
(b)(6) female underwent needle localization wide excision lumpectomy of right breast on (b)(6) 2013. On follow up visit to radiation oncology, was given a copy of ct and told of the need to follow up with surgeon for something that was seen on ct film done in prep for radiation. Seen (b)(6) 2013 by surgeon with finding of a piece of wire felt to be from the needle localization. Wire removed under local in office. Follow up x-ray with no evidence of wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029947 |
| MDR Report Key | 3084838 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-23 |
| Date of Event | 2013-04-16 |
| Date Added to Maude | 2013-05-01 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOTECH |
| Generic Name | HAWKINS III HARDWIRE BLN |
| Product Code | GDM |
| Date Received | 2013-04-23 |
| Lot Number | UNAVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVICE TECHNOLOGIES, INC. |
| Manufacturer Address | 3600 S.W. 47 AVE GAINESVILLE FL 32808 US 32808 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-23 |