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

Model Number C-20360

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 07/10/2019

Event Type  malfunction  

Event Description

The patient didn't feel any alimentary restrictions and once examined it was observed that the reservoir (port) was cracked and was losing serum.

Event Description

The patient didn't feel any alimentary restrictions and once examined it was observed that the reservoir (port) was cracked and was losing serum.

Event Description

The patient didn't feel any alimentary restrictions and once examined it was observed that the reservoir (port) was cracked and was losing serum.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 9177335
• MDR Text Key: 194486616
• Report Number: 3013508647-2019-00053
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR