MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-14 for EZ CLEAN ELECTRODE, NEEDLE, MODIFIED 0013M manufactured by Megadyne Medical Products.
[100072796]
Without the lot number we are unable to identify the manufacturer or expiration date of the device. Repeated requests to the user facility have been unsuccessful in gaining access to the device or obtain additional information for further investigation. Without the lot number we are unable to perform a device history record. A review of the product history reveals this device to be a reliable component of electrosurgery and there is no evidence to suggest a device defect or malfunction. All though we have not been able to confirm the event, the report of a or fire is inherent risk while using electrosurgery and the causes can be various.
Patient Sequence No: 1, Text Type: N, H10
[100072797]
Cautery pencil in use during procedure, resulting in or fire and patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2018-00003 |
| MDR Report Key | 7270798 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-05 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8007476110 |
| Manufacturer G1 | MEGADYNE MEDICAL PRODUCTS |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ CLEAN ELECTRODE, NEEDLE, MODIFIED |
| Generic Name | EZ CLEAN ELECTRODE, NEEDLE, MODIFIED |
| Product Code | JOS |
| Date Received | 2018-02-14 |
| Model Number | 0013M |
| Catalog Number | 0013M |
| 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 DRAPER UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-14 |