COOLIEF MULTI-COOLED RADIOFREQUENCY KIT MCK2-17-100-4 104058802

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-27 for COOLIEF MULTI-COOLED RADIOFREQUENCY KIT MCK2-17-100-4 104058802 manufactured by Avanos Medical Inc..

MAUDE Entry Details

• Report Number: 8030647-2019-00109
• MDR Report Key: 9528260
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-12-27
• Date of Report: 2020-03-05
• Date of Event: 2019-12-04
• Date Mfgr Received: 2020-02-11
• Device Manufacturer Date: 2017-06-29
• Date Added to Maude: 2019-12-27
• 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
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COOLIEF MULTI-COOLED RADIOFREQUENCY KIT
• Generic Name: COOLED RF PROBES AND CANNULAS
• Product Code: GXI
• Date Received: 2019-12-27
• Returned To Mfg: 2019-12-16
• Model Number: MCK2-17-100-4
• Catalog Number: 104058802
• Lot Number: M7164D202
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AVANOS MEDICAL INC.
• Manufacturer Address: 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-12-27