MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-02 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-01-11-T3 manufactured by Devicor Medical Products Inc.
Report Number | 3008492462-2019-00049 |
MDR Report Key | 9269831 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-02 |
Date of Report | 2019-11-01 |
Date of Event | 2018-07-01 |
Date Mfgr Received | 2019-08-26 |
Date Added to Maude | 2019-11-02 |
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. RHONDA KOPS |
Manufacturer Street | 300 E BUSINESS WAY FIFTH FLOOR |
Manufacturer City | CINCINNATI OH 45241 |
Manufacturer Country | US |
Manufacturer Postal | 45241 |
Manufacturer G1 | DEVICOR MEDICAL PRODUCTS DE MEXICO |
Manufacturer Street | SOR JUANAINES DE LA CRUZ #20152 4-B |
Manufacturer City | PARQUE INDUSTRIAL, 22440 |
Manufacturer Country | MX |
Manufacturer Postal Code | 22440 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HYDROMARK BREAST BIOPSY SITE MARKER |
Generic Name | BREAST BIOPSY SITE MARKER |
Product Code | NEU |
Date Received | 2019-11-02 |
Model Number | 4010-01-11-T3 |
Catalog Number | 4010-01-11-T3 |
Device Availability | N |
Device Eval'ed by Mfgr | N |
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. Other | 2019-11-02 |