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

Catalog Number RLZB32

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The investigation has been based on the information provided to date.If further information is received at a later date, a supplemental report will be submitted.

Event Description

It was reported that the port was loose.On adjustments, they couldn't find the port.It was suspected that the port came away from the wall.The band is still implanted.The patient had a endoscopy performed and is scheduled for a barium swallow test.No further details known.

Manufacturer Narrative

(b)(4).Additional information obtained: patient indicates that the band was implanted approximately ten years ago and the port has detached from the muscle wall and has slipped down under and to the left of her ribs.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8416621
• MDR Text Key: 138943273
• Report Number: 3005075853-2019-17206
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: RLZB32
• Device Lot Number: ZKGBDN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/15/2019
• Patient Sequence Number: 1