MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-03 for NODE SEEKER 16340 manufactured by Intramedical Imaging, Llc.
[19366167]
The breast service recently purchased a new node seeker device (instramedical imaging) to replace the old c tracks. The batteries used in the new device appear to have some defect. In the first instance, the battery heated up and leaked inside the probe a month ago. Today the battery supplied by the vendor exploded and shredded inside the charger. I cannot upload a photo to this site or i would show the explosive aftermath. Reason for use: sentinel lymph node biopsy in breast cancer and melanoma. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023728 |
| MDR Report Key | 2403708 |
| Date Received | 2012-01-03 |
| Date of Report | 2012-01-03 |
| Date of Event | 2012-01-03 |
| Date Added to Maude | 2012-01-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NODE SEEKER |
| Generic Name | GAMMA SEED DETECTOR 3.6V |
| Product Code | IZD |
| Date Received | 2012-01-03 |
| Catalog Number | 16340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTRAMEDICAL IMAGING, LLC |
| Manufacturer Address | 12340 SANTA MONICA BLVD STE 227 LOS ANGELES CA 90025 US 90025 |
| Brand Name | ULTRA FIRE BATTERY |
| Generic Name | BATTERY 1000MAH |
| Product Code | IZD |
| Date Received | 2012-01-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTRAMEDICAL IMAGING, LLC |
| Manufacturer Address | 12340 MONICA BLVD STE 227 LOS ANGELES CA 90025 US 90025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-03 |