MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/4/2019.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the patient had a realize band implanted in 2010 or 2012 and had successful weight loss.Now that she¿s lost a great deal of weight and is exercising regularly, the port is sticking out of her abdomen and her original surgeon advised she needed to find a bariatric surgeon in (b)(6) where she now lives.She is being treated by a surgeon who advised the port needed to be removed as there are no replacement ports available.The device was removed (b)(6) 2019.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8962787
• MDR Text Key: 156572444
• Report Number: 3005075853-2019-21671
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2019

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: SAGBX
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other