MAUDE Adverse Event Report: ETHICON, INC. REALIZE Z; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number RLZB32D1

Device Problem Fracture (1260)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 06/04/2018

Event Type  malfunction  

Event Description

Patient had laparoscopic removal of adjustable gastric band on (b)(6) 2018.In (b)(6) 2018 patient presented with abdominal pain.X-ray showed 2 cm segment of tubing in the abdomen or abdominal wall.Patient had a retained segment of tubing in the abdomen - apparently fractured off at the time of the removal.

• Brand Name: REALIZE Z
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 8472777
• MDR Text Key: 140602056
• Report Number: 8472777
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019,02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RLZB32D1
• Device Catalogue Number: RLZB32D1
• Device Lot Number: ZNBBBF
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA