Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND
  • 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
 

RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/05/2021
Event Type  Injury  
Manufacturer Narrative
No device information available.No investigation performed.
 
Event Description
Letter to the editor of obesity surgery magazine: letter to the editor: should we introduce a gastric band removal schedule sonja chiappetta, errichetta napolitano, alfonso bosco.Received: 18 may 2021 /revised: 25 may 2021 /accepted: 25 may 2021.The author(s), under exclusive licence to springer science+business media, llc, part of springer nature 2021.Out of an abundance of caution, this published article was created as a complaint, but should not be treated as a typical complaint.There is no mention of the lap-band, with no identified part number, lot number or serial number.This will be reported as a complaint to the fda.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LAP BAND SYSTEM
Type of Device
ADJUSTABLE GASTRIC BAND
Manufacturer (Section D)
RESHAPE LIFESCIENCES
1001 calle amanecer
san clemente CA 92673
Manufacturer Contact
brian stowe
1001 calle amanecer
san clemente, CA 92673
9494817801
MDR Report Key12271658
MDR Text Key264928845
Report Number3013508647-2021-00026
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
-
-