MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-18 for RAPIDSTRAND RX manufactured by Ge Healthcare.
[4083580]
Report # 2915056-2013-00063 is a health professional report from usa that involves a pt-specific rapidstrand rx implant that contained two incorrectly configured needles. The product autoradiograph showed all needles per treatment plan; however, the facility noted that needle 25 contained 3 seeds (5 were specified) and that needle 26 contained 5 seeds (3 were specified). Qa investigation (b)(4) report pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915056-2013-00063 |
| MDR Report Key | 3482053 |
| Report Source | 05 |
| Date Received | 2013-10-18 |
| Date of Report | 2013-05-16 |
| Date of Event | 2013-05-16 |
| Date Mfgr Received | 2013-05-16 |
| Date Added to Maude | 2014-01-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 101 CARNEGIE CENTER |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6095146000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDSTRAND RX |
| Generic Name | RADIONUCLIDE BRACHYTHERAPY SOURCE |
| Product Code | IWI |
| Date Received | 2013-10-18 |
| Lot Number | 130227A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | ARLINGTON HEIGHTS IL 60004 US 60004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-18 |