MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); Weight Changes (2607)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

Patient reported a lap-band system "leak" first noticed when the patient reported that they "stopped losing weight" and noticed a "loss of restriction." the lap-band system was removed and replaced.

Manufacturer Narrative

Lap-band adjustable gastric banding system (unk size).The product associated with this report will not be returned for analysis.Based upon the partial implant date provided by the reporter the connector type is either a taper ii or rapidport ez strain relief.Visual examination may determine the connector type associated with this report.No additional information has been reported to allergan regarding the serial number or te actual implant date.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNKNOWN ALLERGAN; 71 south los carneros road; goleta CA 93117
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4030339
• MDR Text Key: 4801899
• Report Number: 2024601-2014-00391
• 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: Consumer,Health Professional
• Type of Report: Initial
• Report Date: 07/07/2014

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: 07/07/2014
• Initial Date FDA Received: 07/29/2014
• 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
• Treatment: BLOOD PRESSURE MEDICATION
• Patient Age: 51 YR
• Patient Weight: 147