MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-08-26 for SECURMARK SMARK-EVIVA-13 manufactured by Hologic, Inc.
| Report Number | 1222780-2019-00198 |
| MDR Report Key | 8933002 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 2019-01-08 |
| Date Added to Maude | 2019-08-26 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURMARK |
| Generic Name | BIOPSY SITE TISSUE MARKER DEVICE |
| Product Code | NEU |
| Date Received | 2019-08-26 |
| Model Number | SMARK-EVIVA-13 |
| Catalog Number | SMARK-EVIVA-13 |
| Lot Number | 19A08RD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-26 |