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

Model Number	C-2360
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a leak in the gastric band system.The patient had their gastric band port replaced on (b)(6) 2022.Report was received through fda's medwatch program under mdr report #: mw5106845.
Additional Manufacturer Narrative
The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: michelle ravert ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 13841036
• Report Number: 3013508647-2022-00003
• Device Sequence Number: 3858485
• Product Code: LTI
• UDI-Device Identifier: 10811955020305
• UDI-Public: (01)10811955020305(10)AF01449(17)20191030
• Combination Product (Y/N): N
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: C-2360
• Device Catalogue Number: C-2360
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown