MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number LAP-BAND ADJUSTABLE SYSTEM

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)

Patient Problems Hematoma (1884); Failure of Implant (1924); Pain (1994); Seroma (2069); Obstruction/Occlusion (2422)

Event Date 05/22/2015

Event Type  Injury  

Event Description

Patient reported a lap-band "obstruction," "excruciating pain, seroma, hematoma, drainage" and stated that the band "shifted." the patient also reported that when the doctor went to "deflate" the band prior to removal there was "nothing in it." these events were first noticed when the patient was experiencing "too much pain" making it "difficult to sleep." the lap-band system was removed, but not replaced.These events have not been confirmed by a healthcare professional.

Manufacturer Narrative

The access port connector associated with this report has not been returned and was discarded after surgery based upon the event date and implant date provided by the reporter the connector type is assumed to be a taper ii.Obstruction, seroma, pain, hematoma, drainage, and band slippage are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the catalog number or serial number.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4894156
• MDR Text Key: 18088489
• Report Number: 3006722112-2015-00182
• 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
• Type of Report: Initial
• Report Date: 06/10/2015

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: Health Professional
• Device Catalogue Number: LAP-BAND ADJUSTABLE SYSTEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/01/2015
• 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: NONE PER PATIENT
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 97