MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE, LOW-PROFILE - 14 FR, 1.2 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	2120-14-1.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Granuloma (1876)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 31 aug 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported by the dietitian that the patient developed granulation tissue which has been treated with silver nitrate.The patient was first placed with a feeding tube on (b)(6) 2020 and was moved down a smaller size after leaking developed.Per the patient's mother, the patient also has significant diarrhea.The last tube change occurred on (b)(6) 2020.A contrast study was done and the tube was in the correct position.The patient was seen by the reporter last on (b)(6) 2020, and the patient was still experiencing granulation tissue.It was reported "didn¿t change the current button yesterday as i burned the granulation tissue again which caused (patient) some discomfort." no further information was provided.
Event or Problem Description
Per additional information received on 4 sep 2020, the granulation tissue is extensive and localized around the stoma site.The device remains in place in the patient.It is not known what the patient's future treatment plan will be.
Additional Manufacturer Narrative
All information reasonably known as of 16 sep 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.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 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.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE, LOW-PROFILE - 14 FR, 1.2 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10485102
• Report Number: 9611594-2020-00167
• Device Sequence Number: 2676677
• Product Code: KNT
• UDI-Device Identifier: 00350770984759
• UDI-Public: 00350770984759
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2120-14-1.2
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention