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

Catalog Number RLZB22

Device Problem Malposition of Device (2616)

Patient Problems Vomiting (2144); Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that, ¿major band slip.Couldn¿t eat or drink for weeks.Was only able to sip clear liquids here and there, only able to keep down maybe 4 oz a day of liquid.Choking and aspirating on vomit in my sleep.¿ additional information obtained from the patient; the band was originally implanted in (b)(6) in 2005.Patient could not recall the exact implant date.The last band adjustment was 5 years ago.They decided to have the band removed.It was removed on (b)(6) 2017.Once removed, there was a tremendous amount of scar tissue from where the band had slipped.No fluid in band at the time of removal.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• 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: 7764307
• MDR Text Key: 116469986
• Report Number: 3005075853-2018-11960
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention