MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN PAIN MANAGEMENT PUMP; ELASTOMERIC HFR

Model Number UNKNOWN

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

Patient Problems Tinnitus (2103); Blurred Vision (2137); Ptosis (2620)

Event Date 04/16/2022

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.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.

Event Description

Fill volume: 545 ml, flow rate: 6 ml/hr, procedure: unknown, cathplace: unknown, infusion start time: apr 14, 2022, infusion stop time: unknown.The patient reported that their eye, on surgical side, was droopy and the vision was blurred; it was additionally reported that they experienced ringing in their ears.The patient was advised to clamp the tubing and to contact the anesthesiologist.A follow up phone call to the patient confirmed that they felt much better once the pump was removed, on 16apr2022; they stated that they were doing very well.

Manufacturer Narrative

The device history record for lot 30158844 was reviewed and the product was produced according to product specifications.All information reasonably known as of 18 may 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.

• Brand Name: UNKNOWN PAIN MANAGEMENT PUMP
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14402522
• MDR Text Key: 293354302
• Report Number: 2026095-2022-00052
• 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,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2024
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: 30158844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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: UNSPECIFIED MEDICATION CONCENTRATION 0.2%
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 90 KG