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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN USA/APOLLO ENDOSURGERY, INC. ALLERGAN LAP BAND AP STANDARD W/RAPIDPORT EZ; IMPLANT, INTRAGATRIC FOR MORBID OBESITY
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ALLERGAN USA/APOLLO ENDOSURGERY, INC. ALLERGAN LAP BAND AP STANDARD W/RAPIDPORT EZ; IMPLANT, INTRAGATRIC FOR MORBID OBESITY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)
Event Date 09/12/2019
Event Type  Injury  
Event Description
Discovered dislodged and retained ¿strain relief¿ component following removal of lap band (b)(6) 2017.A (b)(6) year-old female with a history of multiple sclerosis had bariatric lap band surgery in 2012.She continued to have symptoms of reflux and dysphagia and subsequently decided to have laparoscopic lap band removal in (b)(6) of 2017.On (b)(6) 2019, patient again returned to the ed with c/o abdominal pain.Evaluation and ct confirmed retained foreign body.The foreign body was removed and appears to be a ¿strain relief¿ component of the lap band.Segment of catheter tubing located intraperitoneally.Fda safety report id # (b)(4).
 
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Brand Name
ALLERGAN LAP BAND AP STANDARD W/RAPIDPORT EZ
Type of Device
IMPLANT, INTRAGATRIC FOR MORBID OBESITY
Manufacturer (Section D)
ALLERGAN USA/APOLLO ENDOSURGERY, INC.
MDR Report Key9539876
MDR Text Key173511407
Report NumberMW5091986
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 Risk Manager
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age55 YR
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