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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND
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RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Type  Injury  
Manufacturer Narrative
No investigation was performed, as the device was not available for investigation.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories in cpr0001 rev d.No correction or corrective action required.The lot history record was reviewed and no discrepencies or non-conformances recorded.Product was manufactured according to specification.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
 
Event Description
Received a complaint from (b)(6): "patient lapband slip leading to ischemic stomach".
 
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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
minh guong nguyen
1001 calle amanecer
san clemente, CA 92673
8449377374
MDR Report Key14675586
MDR Text Key294903152
Report Number3013508647-2022-00020
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/13/2022
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) Required Intervention;
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