MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ELASTOMERIC HFR

Model Number UNKNOWN

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

Patient Problems Tinnitus (2103); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 25 mar 2021 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).

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the patient experienced metallic taste and ringing in his ears.Patient felt that symptoms stopped once the pump was removed.Patient did not know what medication was in the pump.Pump was a "dial pump." no further information was available.

• Brand Name: UNKNOWN ELASTOMERIC HFR
• Type of Device: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 11574409
• MDR Text Key: 252704834
• Report Number: 2026095-2021-00046
• Device Sequence Number: 1
• Product Code: MEB
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other