MAUDE Adverse Event Report: ETHICON ENDO-SURGERY REALIZE ADJUSTABLE GASTRIC BAND

Model Number RLZB32

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 02/06/2017

Event Type  Injury  

Event Description

Patient has a surgical history of a gastric bypass in 2005 and gastric banding in 2012.Patient was also noted to have had a fall related injury in 2015 striking the area of her gastric band port.Patient presented with nausea, vomiting, and abdominal pain during her most recent admission an egd was performed demonstrating erosion of the gastric band into her gastric pouch.The patient had successful removal of the band on (b)(6) 2017.Ref mfr #300599282-2017-00004.

• Brand Name: REALIZE ADJUSTABLE GASTRIC BAND
• Type of Device: GASTRIC BAND
• Manufacturer (Section D): ETHICON ENDO-SURGERY ; cincinnati OH
• MDR Report Key: 6391526
• MDR Text Key: 69529239
• Report Number: 6391526
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2017
• Device Model Number: RLZB32
• Device Lot Number: ZNG888
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR