MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-18 for Z-SPOT 114 manufactured by Beekley Corporation.
[3022985]
Radiation therapist used a sample of a skin marker for treatment planning on a chemotherapy patient, and when it was removed, it tore off some of the patient's skin with the skin marker.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9021987-2012-00018 |
| MDR Report Key | 2805561 |
| Report Source | 05,06 |
| Date Received | 2012-10-18 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-07-19 |
| Date Mfgr Received | 2012-07-19 |
| Device Manufacturer Date | 2012-04-27 |
| Date Added to Maude | 2012-11-14 |
| 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 Street | ONE PRESTIGE LANE |
| Manufacturer City | BRISTOL CT 06010 |
| Manufacturer Country | US |
| Manufacturer Postal | 06010 |
| Manufacturer Phone | 8605834700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Z-SPOT |
| Generic Name | SYSTEM, X-RAY, FILM MARKING, RADIOGRAPHI |
| Product Code | JAC |
| Date Received | 2012-10-18 |
| Model Number | 114 |
| Catalog Number | 114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEEKLEY CORPORATION |
| Manufacturer Address | BRISTOL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-18 |