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

Catalog Number UNK LAP-BAND

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 02/15/2015

Event Type  Injury  

Event Description

Healthcare professional reported a lap-band port is being removed due to "the port sticking out." the doctor previously tried "to bury the port deeper into the muscle" but it was "still sticking out." additional findings: lap-band port has been explanted.

Manufacturer Narrative

Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the implant date and explant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Visibility/palpability is a surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.No additional information has been reported to allergan regarding the serial number or catalog number.

Manufacturer Narrative

(b)(4).Visual examination of the returned device determined the access port tubing connector to be a taper ii.Analysis noted signs of wear abrasion on the band tubing consistent with wear and tear.Analysis noted a striated opening in the band tubing consistent with surgical removal of the device.

Event Description

Healthcare professional reported a lap-band port is being removed due to "the port sticking out." the doctor previously tried "to bury the port deeper into the muscle" but it was "still sticking out." additional findings: lap-band port has been explanted.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4927678
• MDR Text Key: 6049728
• Report Number: 3006722112-2015-00217
• 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: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LAP-BAND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 64