MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-03 for TOMOSPOT 782 manufactured by Beekley Corporation.
[113078314]
A mole marker caused artifact on a mammogram. As a result, the mammogram was repeated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9021987-2018-00003 |
| MDR Report Key | 7660244 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATE CHASE |
| Manufacturer Street | 1 PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Manufacturer G1 | BEEKLEY CORPORATION |
| Manufacturer Street | 1 PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06010 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9021987-6/14/18-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOMOSPOT |
| Generic Name | MOLE MARKER |
| Product Code | JAC |
| Date Received | 2018-07-03 |
| Model Number | 782 |
| Catalog Number | 782 |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | 1 PRESTIGE LANE BRISTOL CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-03 |