MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE KIT (NON-ENFIT); DH EF BALLOON TUBES PRODUCTS

Model Number 0120-14-2.0

Device Problem Leak/Splash (1354)

Patient Problem Skin Inflammation/ Irritation (4545)

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.A root cause could not be determined.All information reasonably known as of 26 sep 2023 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 reported event but is relaying the information 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 21 cfr 803, 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

It was reported, the mickey tube leaked and the patient experienced stoma redness from the gastric juices.The stoma was treated with over-the-counter creams for several months.The patient¿s physician was notified in june or july and the patient was prescribed "riley's butt cream." the prescription cream healed the stoma site quickly.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE KIT (NON-ENFIT)
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17831015
• MDR Text Key: 324432386
• Report Number: 9611594-2023-00140
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770948454
• UDI-Public: 00350770948454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0120-14-2.0
• 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: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RILEY'S BUTT CREAM
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 43 KG