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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES, INC. ENTUIT THRIVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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XERIDIEM MEDICAL DEVICES, INC. ENTUIT THRIVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 70-0041-118
Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 11/27/2022
Event Type  malfunction  
Event Description
Patient in long term acute care hospital, balloon of peg tube found to be deflated then fell out a month and a half after initial insertion.New peg tube inserted in interventional radiology a week later, without known harm to patient.Documentation of initial insertion identifies that the balloon was inflated with 20cc of sterile water and.5cc of contrast.Manufacturer response for retention feeding tube, entuit br balloon retention catheter (per site reporter).Will check into it.
 
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Brand Name
ENTUIT THRIVE
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
XERIDIEM MEDICAL DEVICES, INC.
4700 s overland dr
tucson AZ 85714
MDR Report Key15995165
MDR Text Key305603605
Report Number15995165
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number70-0041-118
Device Catalogue Number70-0041-118
Device Lot Number10718C001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2022
Device Age2 MO
Event Location Other
Date Report to Manufacturer12/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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