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

Catalog Number LAP-BAND AP ADJUSTABLE GASTRIC

Device Problem Device Slipped (1584)

Patient Problem Tissue Damage (2104)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Pt reported having a lap-band system implanted "five or six years ago." pt stated that "eight months" after the surgery, there was an issue of "band slippage." the problem was first noticed when the pt "could not keep any food down." the pt explained the physician went to fix the "band slippage." and "accidently cut the stomach" while trying to fix it.The physician ended up removing the band portion, but did not remove the port.

Manufacturer Narrative

The product associated with this report has not been returned as the port was not explanted and the status of the band portion is unk.Based upon the time of implant "six or seven years ago" provided by the reporter the connector type is assumed to be a taper ii.Band slippage, reflux, and "accidentally cut the stomach" during repair surgery are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further info from the reporter regarding the event and product info has been requested.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNK ALLERGAN; 71 south los carneros road; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117-5506 ; 8059615867
• MDR Report Key: 4172800
• MDR Text Key: 20975614
• Report Number: 2024601-2014-00568
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/16/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LAP-BAND AP ADJUSTABLE GASTRIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/10/2014
• 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: LEVOTHYROXINE; "BLOOD PRESSURE PILLS"
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64