MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for HAWKINS III BLN (BREAST LOCALIZATION NEEDLE) 244100 manufactured by At The Time, Mfg. Med. Device Tech. Dba Angiotech.
[58356272]
The device was not available for return; therefore, no device evaluation could be conducted. The lot number was not provided. Without a sample to evaluate or a lot number available to conduct device history record reviews, a root cause cannot be established. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58356273]
The tip of the hawkins guidewire fragmented and was retained within a patient's breast. The v shape of the guidewire tip contributed to not detecting fragmentation on the specimen x-ray. The patient required further surgery to to have the tip of the guidewire removed from their breast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2016-00070 |
| MDR Report Key | 6045799 |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-20 |
| Date of Event | 2014-06-09 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-10-20 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | AT THE TIME, ANGIOTECH (SINCE BEEN ACQ. BY ARGON) |
| Manufacturer Street | 3600 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HAWKINS III BLN (BREAST LOCALIZATION NEEDLE) |
| Generic Name | BREAST LOCALIZATION NEEDLE |
| Product Code | GDM |
| Date Received | 2016-10-20 |
| Catalog Number | 244100 |
| Lot Number | UNKNOWN |
| ID Number | NI |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AT THE TIME, MFG. MED. DEVICE TECH. DBA ANGIOTECH |
| Manufacturer Address | 3600 SW 47TH AVE GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-20 |