MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for UNKNOWN RF PROBE manufactured by Avanos Medical Inc..
[136850542]
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of 21-feb-2019 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136850543]
It was reported that a professional literature review a report of the first significant infectious complication of genicular nerve radio frequency ablation (rfa). " summary: the patient had multiple co-morbidities including coronary artery disease with drug-eluding stents, hypertension, diabetes, morbid obesity, osteoarthritis of both knees, and a recent though apparently resolved history of a leukocytosis of unknown origin. The patient underwent an uneventful bilateral coolief rfa of the knees and reported immediate pain relief. However, within 24-hours, the patient reported "fullness" and increasing pain of the left knee. The patient went to the emergency room (er) where a knee aspiration was performed for 60cc of purulent fluid which was positive for staphylococcus aureus. The patient underwent three months of intravenous (iv) antibiotic therapy until the patient was pronounced clear of infection and two months later the patient underwent a left total knee arthroplasty. The authors for the literature review speculate that they traversed the joint capsule during cannulation (with the electrode remaining extra-articular), allowing for the introduction of bacteria into the joint capsule. They stress the importance of vigilance in maintaining sterile technique, considering prophylactic antibiotics, as well as suggesting that a more angular approach might make traversing the joint capsule less likely. Letter to the editor in "american academy of pain medicine-oxford academic. Article entitled "septic arthritis following radiofrequency ablation of the genicular nerves", authored by drs. Ankur khanna, nigel know, and nitin sekhri, published 28-jan-2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2019-00027 |
| MDR Report Key | 8359390 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-02 |
| Date Mfgr Received | 2019-02-02 |
| Date Added to Maude | 2019-02-21 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP 84160 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN RF PROBE |
| Generic Name | COOLED RF PROBES AND CANNULAS |
| Product Code | JOS |
| Date Received | 2019-02-21 |
| 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 | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-21 |