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

Catalog Number B-2245

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 10/07/2013

Event Type  Injury  

Event Description

Healthcare professional reported a lap-band patient who experienced a "wound infection," "port infection with numerous infections involving port and tubing and has had port removed but tubing presents in wound and drains pus," and a "sinus out of original midline incision" that "communicates with foreign body intraperitoneally with marked inflammatory changes." the events were first noticed when the patient was seen for evaluation of the wound infection.The lap-band system was removed, it is not known whether it was replaced.

Manufacturer Narrative

Taper ii.Allergan has received the product; however, the device has not been identified nor has the analysis has not been completed at this time.Based upon the implant 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 received the product; however, the analysis has not been completed at this time.No additional information has not reported to allergan regarding the serial number or model number.Infection, drainage, fistula, and irritation are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event of drainage and infection as follows: there were additional occurrences of these events that were considered to be non-serious.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port dis-placement, port site pain, spleen injury, and wound infection.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zona franka; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 s los carneros rd; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4134987
• MDR Text Key: 19768839
• Report Number: 2024601-2014-00550
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: B-2245
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 123