MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC PEG KIT WITH ENFIT CONNECTORS-14 FR-PULL; DH EF PEG INITIAL PLACEMENT PRODUCTS

Model Number	9640-14
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Malfunction

• Brand Name: MIC PEG KIT WITH ENFIT CONNECTORS-14 FR-PULL
• Common Device Name: DH EF 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: 25816936
• Report Number: 2026095-2026-00060
• Device Sequence Number: 10733895
• Product Code: KNT
• UDI-Device Identifier: 00350770446448
• UDI-Public: (01)00350770446448
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9640-14
• Device Catalogue Number: 9640-14
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/14/2026
• 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
• Patient Sex: Unknown