MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN, ELASTOMERIC LFR

Model Number UNKNOWN

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

Patient Problems Tinnitus (2103); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 05 dec 2022 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.Device not returned.

Event Description

Fill volume: unknown ml.Flow rate: unknown.Procedure: right acl reconstruction.Cathplace: unknown.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.The patient reported, they noted ringing in their ears, drowsiness, and bladder changes; they removed the post procedure (acl) on-q pump at home on (b)(6) 2022; the pump still looked to have about half of the medication still in the ball when it was removed.All the symptoms reportedly resolved except the ¿buzzing¿ in their ears.During follow-up (f/u) with their surgeon, on (b)(6) 2022, the patient noted the ¿buzzing¿ in their ears was still an issue and they were advised to f/u with their physician.The patient reportedly went to physical therapy to treat the dizziness for the ¿ringing¿ in their ears without success, they also tried taking the wax out of their ears.The physician recommended they f/u with an ear nose and throat (ent) specialist.The patient¿s current condition is unknown.

• Brand Name: UNKNOWN, ELASTOMERIC LFR
• Type of Device: ELASTOMERIC LFR
• 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: 15924432
• MDR Text Key: 304896272
• Report Number: 2026095-2022-00132
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• 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: 11/07/2022
• 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
• Treatment: NAROPIN
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female