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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG ENTERALITE INFINITY; FEEDING PUMP

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MOOG ENTERALITE INFINITY; FEEDING PUMP Back to Search Results
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Abdominal Pain (1685); Abdominal Distention (2601)
Event Date 10/16/2016
Event Type  Injury  
Event Description
We have an infinity enteralite feeding pump for our daughter.The bags that hold the formula do not seal completely and let in extra air which gets through the tubing and into her belly via a g-tube.She has had numerous events including excess gas, distended belly and pain around the g-tube site all related to the extra air.
 
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Brand Name
ENTERALITE INFINITY
Type of Device
FEEDING PUMP
Manufacturer (Section D)
MOOG
MDR Report Key6046768
MDR Text Key58180966
Report NumberMW5065541
Device Sequence Number1
Product Code LZH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 10/18/2016
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/18/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age3 MO
Patient Weight4
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