MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for UNK manufactured by Unk.
[35246320]
Device misfire. The needles were subsequently placed through the template in the appropriate positions based on his preoperative dosimetry planning. All seeds placed really quite well with exception of one needle which would be at the positon of c2. 0. We had a needle failure and the seed could not be pushed through the needle. Ultimately these two seeds were lost. This would be a capsular needle placement next to the back wall of the prostate and hopefully should post no problem for the patient. At the very end of the procedure, kub film was taken showing excellent seed placement throughout the prostate gland.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058919 |
| MDR Report Key | 5347497 |
| Date Received | 2015-12-31 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-12-10 |
| Date Added to Maude | 2016-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNK |
| Generic Name | NEEDLE FOR PROSTATE SEED IMPLANT |
| Product Code | IWJ |
| Date Received | 2015-12-31 |
| Returned To Mfg | 1956-08-14 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-31 |