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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M1-5-1212
Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2021
Event Type  malfunction  
Event Description
G tube dislodged/removed.Infant was transferred with a gastrostomy tube (gt).Balloon was found to have a leak.10 fr suction tube used to maintain patency.Balloon on device failed.On inspection device balloon will inflate a small amount but beyond 0.5 ml of air everything just leaks out.This device was placed by an outside facility so no lot number information is available.Manufacturer has been contacted by email.There was no detectable harm.This is all the information available.
 
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Brand Name
MINI ONE BALLOON BUTTON
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
APPLIED MEDICAL TECHNOLOGY, INC.
8006 katherine blvd
brecksville OH 44141
MDR Report Key11472677
MDR Text Key239449085
Report Number11472677
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 Other Health Care Professional
Type of Report Initial
Report Date 03/01/2021
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 Operator No Information
Device Model NumberM1-5-1212
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2021
Event Location Hospital
Date Report to Manufacturer03/12/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/12/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age180 DA
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