MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-06 for MAMMOMARK MAM3008 manufactured by Devicor Medical Products, Inc.
| Report Number | 3008492462-2020-00002 |
| MDR Report Key | 9679771 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-06 |
| 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 | MR. JACK CUMMINGS |
| 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 | MAMMOMARK |
| Generic Name | BIOPSY SITE IDENTIFIER |
| Product Code | NEU |
| Date Received | 2020-02-06 |
| Model Number | MAM3008 |
| Catalog Number | MAM3008 |
| Lot Number | F11924449D |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2020-02-06 |