MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number	RLZB32
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that the realize band was implanted in (b)(6) 2010.Two years later, the patient wasn't able to pass any food, which resulting in vomiting all food eaten.The patient went to her doctor and the doctor notified her there were issues with the realize band and recommended the product be removed.The patient was informed that the band had slipped.The patient had the product removed in (b)(6) 2015.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Common Device Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7317996
• Report Number: 3005075853-2018-08384
• Device Sequence Number: 105178
• Product Code: LTI
• UDI-Device Identifier: 20705036004001
• UDI-Public: 20705036004001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1