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

Model Number C-20365

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

Leak test performed with methylene blue.Obvious leak from exposed tubing due to lack of armadillo.Port removed.Port replaced.

Manufacturer Narrative

The reported complaint for leak and broken strain relief were confirmed.The cause of the leak was a hole in the tubing at the port stem likely caused by the detachment of the strain relief leading to a needle puncture.The cause of the detached strain relief was not determined.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GATRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 11385920
• MDR Text Key: 239129907
• Report Number: 3013508647-2021-00006
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Device Lot Number: AF00687
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 108