MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN FEEDING TUBE; DH EF BALLOON TUBES PRODUCTS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 07/05/2019

Event Type  Injury  

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 24 jul 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 halyard health complaint database and identified as complaint (b)(4).

Event Description

It was reported that while the patient was hospitalized for urinary tract infection and clogged urinary catheter (unknown), it was noted that the patient's mic key stoma was sensitive and inflamed.The "start of a bud is present" and the facility recommended silver nitrate for treatment, as well as an abdominal ultrasound.Additional information was requested but has not been provided at this time.

Manufacturer Narrative

All information reasonably known as of 19 sep 2019 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: UNKNOWN FEEDING TUBE
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8844201
• MDR Text Key: 152760167
• Report Number: 9611594-2019-00145
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR