MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG KIT WITH ENFIT CONNECTOR; DH CPK PEG INITIAL PLACEMENT PRODUCTS

Model Number	50-6016E2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional 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; therefore, the udi-pi is unavailable.All information reasonably known as of 15 dec 2025 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 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 or Problem Description
It was reported, ¿a 52-year-old patient was hospitalized on (b)(6) 2025, for a gastrostomy tube replacement.Chronology of events: (b)(6) 2025: initial placement of a corflo gpe gastrostomy tube using the pull technique.The endoscopy nurses provided the patient's nurses with information regarding gastrostomy care.(b)(6) 2025: a follow-up appointment with the physician at 3 weeks was scheduled.During this appointment, a skin erosion around the gastrostomy site was observed, due to pressure from the external flange.A hydrocolloid dressing was applied to the erosion, and a prescription was issued to continue care.The tube's skin fixation system is a rigid clip system, difficult to dislodge.The patient was given the tube supplier's information booklet.(b)(6) 2025: following a consultation with a hepatologist, it was noted that the gastrostomy opening was inflamed and painful.(b)(6) 2025: the gastrostomy tube was changed to a standard balloon tube with a flanged fixation system.Patient's current condition: significant lesions at the gastrostomy site.Reoperation for tube replacement in a frail patient.The patient is currently hospitalized in a vascular rehabilitation unit (in the context of amputation).Actions taken at the healthcare facility for the patient's care: tube replacement on (b)(6) 2025 with a balloon-type tube using a different skin fixation system: a wide, flexible, transparent collar that is much less traumatic.The device was not retained, and no expert analysis can be performed.".

• Brand Name: CORFLO PEG KIT WITH ENFIT CONNECTOR
• Common Device Name: DH CPK PEG INITIAL PLACEMENT PRODUCTS
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 23827761
• Report Number: 2026095-2025-00036
• Device Sequence Number: 21154227
• Product Code: KNT
• UDI-Device Identifier: 00350770469416
• UDI-Public: (01)00350770469416
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 50-6016E2
• Device Catalogue Number: 50-6016E2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male