MAUDE Adverse Event Report: RESHAPE LIFESCIENCES RAPIDPORT EZ ACCESS PORT KIT; ADJUSTABLE GASTRIC BAND

Device Problem Device Slipped (1584)

Patient Problems Abdominal Pain (1685); Erosion (1750); Necrosis (1971)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

Patient had abdominal pain and xrays test found band slipped and necrotic stomach above band.The band removed and necrotic stomach was resected.The patient did well and went home, no further issues.

• Brand Name: RAPIDPORT EZ ACCESS PORT KIT
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente, ca
• Manufacturer (Section G): APOLLO ENDOSURGERY; building b 13.3; alajuelaike, ; CS
• Manufacturer Contact: kristin wielenga ; 1001 calle amanecer; san clemente, ca
• MDR Report Key: 10417518
• MDR Text Key: 204394210
• Report Number: 3013508647-2020-00028
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/17/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention