MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-15 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T4 manufactured by Devicor Medical Products, Inc..
| Report Number | 3008492462-2019-00040 |
| MDR Report Key | 8897042 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-08-15 |
| Date of Report | 2019-08-15 |
| Date of Event | 2019-07-18 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2018-04-11 |
| Date Added to Maude | 2019-08-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JILL BURNETT |
| Manufacturer Street | 300 E. BUSINESS WAY FIFTH FLOOR |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer G1 | DEVICOR MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 300 E. BUSINESS WAY FIFTH FLOOR |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45241 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROMARK BREAST BIOPSY SITE MARKER |
| Generic Name | BIOPSY SITE MARKER |
| Product Code | NEU |
| Date Received | 2019-08-15 |
| Model Number | 4010-02-15-T4 |
| Catalog Number | 4010-02-15-T4 |
| Lot Number | 200044907 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 300 E. BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-15 |