MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-02 for E-Z CLEAN ELECTRODE 0012M manufactured by Megadyne Medical Products.
[90890548]
All attempts to gain information about the patient or the event have been unsuccessful. Without lot number information we are unable to identify the manufacture date. A review of product history reveals this device to be a reliable component of electrosurgery and there is no evidence to suggest a device defect or malfunction.
Patient Sequence No: 1, Text Type: N, H10
[90890549]
Secondary burn utilizing a 0012m with a medline pencil is an ent procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2017-00008 |
| MDR Report Key | 6996780 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-02 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS STACEY CASTANEDA |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8007476110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z CLEAN ELECTRODE |
| Generic Name | E-Z CLEAN ELECTRODE, BLADE, MODIFIED |
| Product Code | JOS |
| Date Received | 2017-11-02 |
| Model Number | 0012M |
| Catalog Number | 0012M |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-02 |