MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for IOVERA SMART TIP (3X6.9MM) STT0513 manufactured by Myoscience.
[117748433]
Broken needle tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079227 |
| MDR Report Key | 7797230 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-07-17 |
| Date Added to Maude | 2018-08-20 |
| 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 | IOVERA SMART TIP (3X6.9MM) |
| Generic Name | DEVICE, SURGICAL, CRYOGENIC |
| Product Code | GXH |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-08-06 |
| Model Number | NA |
| Catalog Number | STT0513 |
| Lot Number | 3441 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYOSCIENCE |
| Manufacturer Address | FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-17 |