MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-15 for AQUAMANTYS GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[4831524]
Company representative received a report from doctor stating that during a post-operative checkup (after successful tka procedure using the aquamantys system) a patient presented with a cellulitis infection. Antibiotics were administered to the patient and the infection was reported to have cleared and patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
[12286801]
(b)(4). (method, result and conclusions): generator still in use at facility, therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00086 |
| MDR Report Key | 4088128 |
| Report Source | 06,07 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-08-18 |
| Date Added to Maude | 2014-09-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUAMANTYS GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-09-15 |
| Model Number | 40-402-1 |
| Catalog Number | 40-402-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-15 |