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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER FEEDING TUBE ATTACHMENT DEVICE (FTAD); TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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HOLLISTER INCORPORATED HOLLISTER FEEDING TUBE ATTACHMENT DEVICE (FTAD); TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 9785
Device Problem Product Quality Problem (1506)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/19/2021
Event Type  No Answer Provided  
Event Description
Hollister feeding tube attachment device (ftad) inserted (b)(6) 2021 and removed (b)(6) 2021.On (b)(6) 2021 a pressure injury was noted on the nose.A less severe but similar event with the same device occurred in february.Both patients were male and this patient had large nose.The size of the nose on the first patient was not noted.Rns tape over the securement devices to keep them in place because the securement devices move when patients sweat; contrary to product instructions which state to use a new securement device.Fda safety report id# (b)(4).
 
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Brand Name
HOLLISTER FEEDING TUBE ATTACHMENT DEVICE (FTAD)
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key12348289
MDR Text Key267835242
Report NumberMW5103363
Device Sequence Number2
Product Code KNT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/17/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9785
Device Catalogue Number9785
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/19/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight105
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