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

Model Number	8644-14
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for lot 0002991911 was reviewed and the product was produced according to product specifications.Photos of the device were requested but were not available.Root cause could not be determined.All information reasonably known as of 15 jul 2020 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.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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the patient felt pain when handling the gastrostomy tube 6 months after placement.Fibroscopy was performed on (b)(6) 2020 and it was found that the "probe retention system was no longer visible in the wall." surgical removal of the retention system [bumper] was required.The patient received antibiotic treatment for a "clinical and biological inflammatory syndrome." additional information received 30-jun-2020 indicated "the factors favoring the inclusion of the device in the gastric wall in this case are probably a rapid and significant weight gain, and a heavy immunosuppressive treatment, therefore weakened ground and the appearance to the block shows a gradual migration of the device.Patient's condition is fine.".

• Brand Name: MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 14 FR
• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10285690
• Report Number: 3006646024-2020-00027
• Device Sequence Number: 14166503
• Product Code: KNT
• UDI-Device Identifier: 00350770446264
• UDI-Public: 00350770446264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 8644-14
• Device Catalogue Number: 104462600
• Device Lot Number: 0002991911
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Weight: 72