MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-06 for COOK * DKBL-20-9.0-1 manufactured by Cook, Inc..
[497766]
After complaints of pain, inflammation, and discoloration in pt's right breast, pt returned to surgery on 05/25/06 for removed of wire fragments from a needle localization wire that was used on 10/20/05 for a breast biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 753495 |
| MDR Report Key | 753495 |
| Date Received | 2006-07-06 |
| Date of Report | 2006-06-01 |
| Date of Event | 2006-05-25 |
| Date Facility Aware | 2006-05-25 |
| Report Date | 2006-06-01 |
| Date Reported to Mfgr | 2006-06-02 |
| Date Added to Maude | 2006-08-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK |
| Generic Name | MODIFIED DISP KOPANS SPRING HOOK LOCALIZATION NEEDLE |
| Product Code | MIJ |
| Date Received | 2006-07-06 |
| Model Number | * |
| Catalog Number | DKBL-20-9.0-1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 741304 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY PO BOX 489 BLOOMINGTON IN 474020489 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-07-06 |