MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problems Device Slipped (1584); Positioning Problem (3009)

Patient Problem Abdominal Pain (1685)

Event Date 01/01/2013

Event Type  Injury  

Event Description

It was reported that the original band placed on (b)(6) 2009 with a loss of 80 lbs.In 2012 the band slipped.A revision was done in (b)(6) 2013.It was reported, "the original band was removed and stapled back into place".It was also reported that whatever was ate or drank sat on top of the band and was very painful.Doctor¿s visits were every two weeks since the end of march.During the time the band slipped and the time the band was replaced, almost all lost weight was gained back.In (b)(6) 2014 all the fluid was removed to see if there was any obstruction.An endoscopy in (b)(6) 2014 did not show the reason for pain in the center of the abdomen.The band was stretched out at that time.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

• 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: 4097010
• MDR Text Key: 15116866
• Report Number: 3005992282-2014-00053
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2014

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: 08/28/2014
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1