MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for MAMMOMARK BREAST BIOPSY REF MAM3008 manufactured by Mammotome/devicor Medical Products, Inc.
[183546474]
Biopsy marker clip broke off and was embedded inside the patient's right breast after biopsy. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093702 |
| MDR Report Key | 9823770 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-07 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMMOMARK BREAST BIOPSY |
| Generic Name | MARKER, RADIOGRAPHIC, IMPLANTABLE |
| Product Code | NEU |
| Date Received | 2020-03-11 |
| Model Number | REF MAM3008 |
| Lot Number | F119244490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAMMOTOME/DEVICOR MEDICAL PRODUCTS, INC |
| Manufacturer Address | CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |