MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-02 for SUCTION COAGULATOR UNKNOWN manufactured by Megadyne Medical Products, Inc..
[66355211]
Without lot number information we are unable to identify the manuafacturer date and perform a review of the lot history. A review of product history reveals this device to be a reliable componet of electrosurgery and there is no evidence to suggest device defect or malfunction. Megadyne determined this event is likely related to surgical technique. Information received indicates that the physician could not find the coagulating edge of this instrucment. Megadyne is reporting since the information indicates intervention was performed. Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[66355212]
Dr. (b)(6) was doing a turbinate reduction and after reduction of the turbinates he was using 8 french suction coagulator to coagulate the nasal bleeding. When he was unable to coagulate he switched to 10 french suction coagulator. He was still unable to achieve hemostasis and ended up packing the bleeding tissue with cocaine to stop the bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2017-00004 |
| MDR Report Key | 6296232 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-02 |
| Date Mfgr Received | 2017-01-05 |
| Date Added to Maude | 2017-02-02 |
| 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 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8015769669 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUCTION COAGULATOR |
| Generic Name | SUCTION COAGULATOR |
| Product Code | DWG |
| Date Received | 2017-02-02 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-02 |