MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-30 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-9.0-A manufactured by Cook, Inc..
[2753168]
A part of the wire broke off and remained in the breast. This was not apparent until the pt came back for a 3 months f/u. The piece has not been removed from the pt at this time. The pt is returning for a procedure in which it may be possible for the surgeon to remove the debris, but it is from a certainty that the debris will be retrieved.
Patient Sequence No: 1, Text Type: D, B5
[9835570]
Lot # not provided by reporter. Exp date: unk as lot # is unk. (b)(4) - nonresorbable materials, unretrieved body is not listed in the instructions for use. (b)(4) - separates is not listed in the instructions for use. (b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00197 |
| MDR Report Key | 2562032 |
| Report Source | 06 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-06 |
| Date of Event | 2011-12-20 |
| Date Facility Aware | 2011-12-20 |
| Report Date | 2012-04-06 |
| Date Mfgr Received | 2012-04-06 |
| Date Added to Maude | 2012-05-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MGR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-04-30 |
| Model Number | NA |
| Catalog Number | DKBL-20-9.0-A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-30 |