MAUDE Adverse Event Report: ETHICON REALIZE GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Abdominal Distention (2601)

Event Date 07/19/2016

Event Type  Injury  

Event Description

A (b)(6) y/o female had a realize gastric band placed in (b)(6) 2012.Removed in (b)(6) 2012.She continued to have pain in the ruq along with a bulge.During the current surgery, a portion of the band cuff was recognized within the fascial defect.The piece of the band was dissected and sent to pathology.The pt was d/c without incident.

• Brand Name: REALIZE GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6816537
• MDR Text Key: 83641949
• Report Number: MW5071775
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2017

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: RLZB32
• Device Lot Number: ZMKBCK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR