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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAP BAND
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LAP BAND Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 01/15/2015
Event Type  Injury  
Event Description
Lap band slipped, was unable to eat or drink by mouth.Spent 8 days in hospital, had surgery to remove band.
 
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Brand Name
LAP BAND
Type of Device
LAP BAND
MDR Report Key7112205
MDR Text Key94854612
Report NumberMW5073948
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Weight100
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