MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORGRIP NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM; DH CPK CORGRIP TUBE RETENTION

Model Number	25-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 19-feb-2021 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).
Event or Problem Description
It was reported the corgrip tube retention device caused nasal erosion and wound care therapy was required for the patient.Additional information received 28-jan-2021 stating the device was placed on (b)(6) 2021 and the wound was noted on (b)(6) 2021.Medical intervention entailed a wound care consult, with additional wound follow-up and the tube retention device was repositioned.The patient is reported to be "recovering.".
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided and confirmed the reported incident.A root cause was not identified.All information reasonably known as of 29-apr-2021 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).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: CORGRIP NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM
• Common Device Name: DH CPK CORGRIP TUBE RETENTION
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11349866
• Report Number: 3011270181-2021-00006
• Device Sequence Number: 17176735
• Product Code: KNT
• UDI-Device Identifier: 00350770458366
• UDI-Public: 00350770458366
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K162110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 25-010
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR