MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN COLLED RF PROBE; PAIN MANAGEMENT GENERATORS & ACCESSORIES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Death (1802); Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient code(s)-no code available: foreign body and bleeding.Note: search of the maude database did not reveal any new reports previously unknown to avanos.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 17-dec-2020 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 comp-ghc-20-03333.

Event Description

It was reported via a poster at the virtual asra conference entitled "comparing adverse events associated with traditional and cooled radiofrequency ablation: a retrospective database review" that several injuries occurred from use of the device.The data used for the presentation was reportedly obtained from the maude database noting the years 2010 through 2020.The criteria used in the maude search, as well as individual maude reference numbers were not provided.It is not possible to determine how many devices or patients were involved.No specific details for the referenced events was provided from the poster at the virtual asra conference.Additional information has been requested.

• Brand Name: UNKNOWN COLLED RF PROBE
• Type of Device: PAIN MANAGEMENT GENERATORS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 11038364
• MDR Text Key: 222374202
• Report Number: 8030647-2020-00118
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other