Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY MINIONE GASTRSOTOMY TUBE BUTTON; GASTRIC TUBE, IMPLANTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL TECHNOLOGY MINIONE GASTRSOTOMY TUBE BUTTON; GASTRIC TUBE, IMPLANTED Back to Search Results
Catalog Number M1-5-1410
Device Problems Deflation Problem (1149); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2016
Event Type  Injury  
Event Description
Pt status post g-tube placement, d/c'd (discharged) to home three days later.Patient presented to the emergency department with a g-tube complication approximately 2 days after discharge.Pt was at home when balloon of gt became partially deflated.Mother brought patient to er where the button was evaluated by surgery, dye study showed that the gt was not in place and pt was taken back to the operating room for a diagnostic lap and gtube insertion by attending surgeon.Pt has since been d/c'd in stable condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINIONE GASTRSOTOMY TUBE BUTTON
Type of Device
GASTRIC TUBE, IMPLANTED
Manufacturer (Section D)
APPLIED MEDICAL TECHNOLOGY
8006 katherine blvd
brecksville, OH 44141
MDR Report Key5681356
MDR Text Key45964409
Report Number5681356
Device Sequence Number1
Product Code PIF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 05/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Catalogue NumberM1-5-1410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2016
Device Age5 DY
Event Location Home
Date Report to Manufacturer05/12/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Weight6
-
-