MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for KOPANS G03507 manufactured by Cook, Inc..
[48433891]
Patient Sequence No: 1, Text Type: N, H10
[48433892]
The tip of a breast lesion localization wire had broken inside the patient's breast. Provider was unable to locate and retrieve the tip when performing surgery. This was disclosed to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5757862 |
| MDR Report Key | 5757862 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-16 |
| Report Date | 2016-06-27 |
| Date Reported to FDA | 2016-06-27 |
| Date Reported to Mfgr | 2016-06-27 |
| Date Added to Maude | 2016-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS |
| Generic Name | NEEDLE, TUMOR LOCALIZATION |
| Product Code | MIJ |
| Date Received | 2016-06-29 |
| Catalog Number | G03507 |
| Lot Number | 6807081 |
| ID Number | DKBL-21-7.0-A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |