MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB QUICKCLOSE WITH VELOCITY; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Device Slipped (1584)

Patient Problems Bleeding (1738); Transfusion of blood products (2337); Surgical procedure, additional (2564)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported that the realize band was originally placed in (b)(6), 2010.The patient did not know which band she had placed and doesn't know what her maximum fill was.In (b)(6), 2014 the patient was hospitalized and had surgery for a gi bleed and removal of her band due to slippage.During this procedure, the patient was given a unit of blood due to bleeding.The patient had two scope procedures and a colonoscopy during a hospitalization just prior to the hospitalization for the gi bleed and band removal.The patient also said the band was effective for her and she lost 110 pounds with the band, but since its removal, she has regained 45 pounds.She wants a new band placed but is waiting to find out from her surgeon if he recommends replacing the band.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.

• Brand Name: SAGB QUICKCLOSE WITH VELOCITY
• 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-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4573779
• MDR Text Key: 5475507
• Report Number: 3005992282-2015-00009
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1