MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the parents had called [the hospital], that the child¿s peg [percutaneous endoscopic gastrostomy] area was tender, the physician had scheduled an appointment for friday the same week.On (b)(6) 2021 a paediatric surgeon placed a mic-key enteral feeding tube into the patient using the introducer kit-technique.Besides the pediatric surgeon, a pediatrician had been present at the endoscopy.The patient was discharged on (b)(6) 2021.On (b)(6) 2021 the family members had called the hospital, the child¿s peg [percutaneous endoscopic gastrostomy] area was tender, the physician had scheduled an appointment for friday the same week.On (b)(6) 2021 the patient had been brought to the emergency room due to tenderness, redness and pain in the peg [percutaneous endoscopic gastrostomy] area.Ultrasound of the abdomen had been performed.On (b)(6) 2021, granuloma [had been observed] in the area of the feeding port (mic-key), as well as an abscess at the root of the gastropexy (at the root of the anchor button).Abscess had been punctured and cleaned.During this time, the gastropexy buttons had fallen out at the right time (which is usually approximately 3 weeks for children).Recently, the family member had noticed something bright on the skin, around the area of the gastropexy button.From the skin, the anchor had drilled out, which the family member had removed.The granuloma has been treated with elocon (mometasone furoate) emulsion, which has been found to be good.Additional information received 12-may-2022 stated on (b)(6) 2021, peg had been placed in (b)(6) hospital.Peg was quite neat at the beginning, but there was an abscess twice in the area of anchor buttons and the child was even hospitalized between (b)(6) 2022 and (b)(6) 2022.The surgeon had punctured the abscess and wound treatment had been carried out.The child had been all the time sore in the peg area, so that she had not agreed to crawl or be on her stomach, even when embracing the child there had been a tenderness in the abdominal area.Peg also had granuloma at the root, which was initially treated with silver nitrate according to the physician's instructions, but it had not helped much.On (b)(6) 2022, the use of elocon (mometasone furoate) ointment was started as a course (one week of ointment and one week without ointment).The growth of peg granuloma had decreased with the ointment.On (b)(6) 2022, the child's mother had noticed something shiny on the scar of the anchor button and the anchor had come through the skin.Since then, the skin has been neat, the tenderness, pain and redness has decreased.
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.Root cause could not be determined.All information reasonably known as of 31-may-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, inc.Complaint database and identified as complaint (b)(4).

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT 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: 14569225
• Report Number: 9611594-2022-00074
• Device Sequence Number: 5901716
• Product Code: KNT
• UDI-Device Identifier: 00350770984308
• UDI-Public: 00350770984308
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K080253
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 98430
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 1 YR
• Patient Sex: Female