MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for LELOC TUMOR LOCALIZER 9896-032-03272 manufactured by Invivo Corporation.
[73617581]
When removed from shipping container, device was noted to have a bent needle, 175 degrees. Did not reach a patient, was unable to be stocked for use, returned to manufacturer for refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069253 |
| MDR Report Key | 6515367 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-04-15 |
| Date Added to Maude | 2017-04-24 |
| 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 | LELOC TUMOR LOCALIZER |
| Generic Name | STRIP TEST ISONIAZID |
| Product Code | MIG |
| Date Received | 2017-04-20 |
| Returned To Mfg | 2017-04-15 |
| Model Number | 9896-032-03272 |
| Lot Number | 610046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |