MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-05 for BEEKLEY SPOTS DESIGNED FOR DIGITAL SKIN MARKER 752 NA manufactured by Beekley Corporation.
[2769039]
The technologist was unaware that the o-ring had fallen off the mole marker during the mammogram until she viewed the image which showed the mole but not the mole marker. The technologist needed to replace the mole marker and re-image.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9021987-2012-00005 |
| MDR Report Key | 2655827 |
| Report Source | 06 |
| Date Received | 2012-07-05 |
| Date of Report | 2012-07-05 |
| Date of Event | 2012-06-27 |
| Date Mfgr Received | 2012-06-27 |
| Device Manufacturer Date | 2012-04-17 |
| Date Added to Maude | 2012-07-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHELSEA FITHIAN |
| Manufacturer Street | ONE PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9021987-07/05/2012-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEEKLEY SPOTS DESIGNED FOR DIGITAL SKIN MARKER |
| Generic Name | NA |
| Product Code | JAC |
| Date Received | 2012-07-05 |
| Model Number | 752 |
| Catalog Number | NA |
| Lot Number | A040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | ONE PRESTIGE LANE BRISTOL CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-05 |