MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-13 for HAWKINS BLN 20G X 7.5CM 251075 manufactured by Argon Medical Devices.
[5594556]
Physician was preparing localizing needle and the needle hub was bent not allowing hub to be loosened for the needle to advance. Diagnosis or reason for use: for breast localization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041522 |
| MDR Report Key | 4617004 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-13 |
| Date of Event | 2015-02-09 |
| Date Added to Maude | 2015-03-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HAWKINS BLN 20G X 7.5CM |
| Generic Name | HAWKINS BLN 20G X 7.5CM |
| Product Code | MIJ |
| Date Received | 2015-03-13 |
| Returned To Mfg | 2015-03-06 |
| Catalog Number | 251075 |
| Lot Number | 1067177 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES |
| Manufacturer Address | ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-13 |