• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN ALLERGAN LAP-BAND AP SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

  • 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
 

ALLERGAN ALLERGAN LAP-BAND AP SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Catalog Number B-2240
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fistula (1862); Vomiting (2144); Hernia (2240); Weight Changes (2607)
Event Date 02/23/2016
Event Type  Injury  
Event Description
Patient brought to operating room for lap band removal due to recent vomiting, feeling fullness in chest and weight gain.Lap band removed by surgeon.Pt also noted to have incisional hernia and gastric fistula.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALLERGAN LAP-BAND AP SYSTEM
Type of Device
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Manufacturer (Section D)
ALLERGAN
301 west howard lane suite 100
austin TX 78753
MDR Report Key5466147
MDR Text Key39217957
Report Number5466147
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Expiration Date04/30/2013
Device Catalogue NumberB-2240
Device Lot Number16635584
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2016
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer02/25/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age58 YR
-
-