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

Model Number C-2360

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The patient had the lap band implanted in (b)(6) 2018.Subsequently, in the spring of 2020, the band came undone and broke inside the patient.Device was discarded by the site and not available to be returned.

Event Description

The patient had the lap band implanted in (b)(6) 2018.Subsequently, in (b)(6) 2020, the band came undone and broke inside the patient.Device was discarded by the site and not available to be returned.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente, ca
• MDR Report Key: 10309438
• MDR Text Key: 200818458
• Report Number: 3013508647-2020-00022
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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
• Device Expiration Date: 03/15/2020
• Device Model Number: C-2360
• Device Catalogue Number: C-2360
• Device Lot Number: AF01674
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention