MAUDE Adverse Event Report: BIOENTERICS CORPORATION; IMPLANT, INTRAGASTRIC

Catalog Number 63LD06

Device Problem Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Weight Changes (2607)

Event Date 07/24/2013

Event Type  Injury  

Event Description

Patient was gaining weight with gastric lap band that was implanted eight years ago.The device was retaining the water.Consequently, the device was removed and another procedure was performed.

• Type of Device: IMPLANT, INTRAGASTRIC
• Manufacturer (Section D): BIOENTERICS CORPORATION; 1035 cindy lane; carpinteria CA 93013
• MDR Report Key: 3689555
• MDR Text Key: 4301985
• Report Number: 3689555
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 63LD06
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2014
• Device Age: 8 YR
• Event Location: Home
• Date Report to Manufacturer: 03/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 87