MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2015-03-27 for MICK SHIELDED DISPOSABLE MAGAZINE 0216-DS manufactured by Mick Radio-nuclear Instruments, Inc..
[21551832]
During a prostate seed implant (ldr prostate brachytherapy) at (b)(6), it was reported that while using a muck magazine there was an incident reported to the eu complaint handling system. There were 3 seeds (out of 15 seeds in a magazine) that were not implanted per the dosimetry plan due to the 3 seeds not ejecting properly from the magazine. In an interview with the physician involved in the surgery, it was stated that the dosimetry was re-planned and the implant continued. After the implant was completed, it was identified via ct that there were 3 seeds not implanted. It was also reported that the pt was not injured nor was there med or surgical intervention required in the incident. Please note that the mick magazine is the delivery device for the radioactive seeds and remains outside the body while the seeds are implanted. It is an accessory to the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431392-2015-00001 |
| MDR Report Key | 4658389 |
| Report Source | 01 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-27 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2015-03-01 |
| Date Added to Maude | 2015-04-06 |
| 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 | 521 HOMESTEAD AVE. |
| Manufacturer City | MOUNT VERNON NY 10550 |
| Manufacturer Country | US |
| Manufacturer Postal | 10550 |
| Manufacturer Phone | 9146673999 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICK SHIELDED DISPOSABLE MAGAZINE |
| Generic Name | MICK MAGAZINE |
| Product Code | IWJ |
| Date Received | 2015-03-27 |
| Model Number | 0216-DS |
| Catalog Number | 0216-DS |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
| Manufacturer Address | 521 HOMESTEAD AVE. MOUNT VERNON NY 10550 US 10550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-27 |