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 Bacterial Infection (1735); Urinary Retention (2119)

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 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.

Event Description

Fill volume: unknown.Flow rate: 2 gram every 8 hrs.Procedure: spine surgery.Cathplace: neck.Infusion start time: unknown.Infusion stop time: unknown.Fda medwatch / fda user facility report # mw5112178 received on (b)(6) 2022, reported, ¿my wife has a bacterial infection that developed after spine surgery; the surgeon recommended a peripherally inserted central catheter (picc) line medication treatment from [a] local infectious disease (id) consultant.My wife was given an iv picc line and started with cefepime medication; dosage 2gm, every 8 hours for a duration of forty-two (42) days.On sunday, my wife experienced trouble with urinating (she had the sensation to urinate but could only expel small amounts of urine).The infectious disease staff was contacted, and my wife was told to drink more water and contact their office the following monday.My wife stopped taking additional treatments and contacted the infectious disease staff today.The id pharmacists said he was going to inform the medical doctor (md) and get back to us for further instructions.¿ the patient¿s current status was not reported.Additional information received (b)(6) 2022, the patient¿s spouse reported, the patient developed an infection, at the neck incision, shortly after having spinal surgery; she reportedly stopped taking the at-home picc line medication for 3 days.The patient has resumed taking treatments at-home after being advised by the infectious disease physician to do so.The medication ball was temporarily connected to a stationary picc line in her arm every day, 3 times a day for approximately 45 minutes.She has been on this medication for 4 weeks and has approximately 2 more weeks to complete for a total of 42 days.She is seen by the infectious disease staff once a week and sees the physician once every month.The patient was reportedly doing fine and was making sure to have ¿good water intake, her neck incision was healing well.Additional information received (b)(6) 2022 reported, the surgery was on (b)(6) 2022, the infection developed around (b)(6) 2022, the symptoms included: redness, discolored drainage, and a ¿bb¿ sized hole on the rear neck incision.The surgeon performed a wash on (b)(6) 2022, the picc line medication was started on (b)(6) 2022.The patient was notified by the infectious disease pharmacist, on (b)(6) 022, that effective immediately they are reducing the picc line medication ball to 1 gm every 8 hours.

Manufacturer Narrative

All information reasonably known as of 19 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.

• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 15696428
• MDR Text Key: 302681561
• Report Number: 2026095-2022-00112
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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: Health Professional
• 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: 10/11/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/26/2022
• 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: CEFEPIME EVERY 8 HOURS FOR 42 DAYS
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG