MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/18/2016.Information asked for but unknown or not provided during initial contact.Information unavailable.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Batch # unk.

Event Description

It was reported that following laparoscopic sagb insertion the patient underwent a laparoscopic band, tubing and port removal procedure on (b)(6) 2015.The patient stated that, following the sagb insertion procedure, she did well with the band, however, had some occasional vomiting but did experience a weight loss of 88 lbs.Approximately three years after the procedure in 2012 she experienced more issues.She would begin to eat and food would ¿get stuck¿ and then she would vomit.The bariatric practice she now saw for band fills had a hard time locating the port (it took ¿several pokes¿ to find the port) versus the bariatric practice she had seen when she first had the band put in which didn¿t have a hard time finding the port.She gained weight and in mid-(b)(6) 2014 she went to an emergency room for pain.The bariatric physician that she saw in the emergency room removed the fluid in the band but left the band in place.Even without fluid in the band, the patient stated that she still experienced restriction and could only eat a part or only half of each meal.Depending on the foods she ate, she would vomit after meals.On (b)(6) 2015 the patient experienced pain on her left side and felt as if she was going to pass out.That night the pain was in her pelvic area and in the morning on (b)(6), the pain was on her right side.The patient went to an urgent care facility, on (b)(6).She was sent home with a prescription for gas pills.She used a heating pad for the pain and took the prescription gas pills; however, she was still in pain.On (b)(6), a ct scan was done.The patient was told that the band, tubing and port had migrated into her pelvic area.The bariatric surgeon was called and surgery was scheduled for tuesday, (b)(6).The bariatric surgeon removed the band, the tubing and the port during a laparoscopic procedure on (b)(6).

Manufacturer Narrative

(b)(4).

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5444995
• MDR Text Key: 38489891
• Report Number: 3005992282-2016-00003
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1