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

Catalog Number RLZB22

Device Problem Fluid/Blood Leak (1250)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

It was reported that in (b)(6) 2014 the patient stopped feeling restriction.An x-ray was performed and looked at for placement.It was determined the band was in the proper place.In addition, a barium swallow was performed and it was reported the test did not show any restriction.The surgeon wanted to determine if there was a slow leak in the band so 5ml was placed in the band on (b)(6), 2014.The patient will return on (b)(6), 2014 to check for leaks.If a leak is detected, the surgeon will inject contrast into the port and take films to determine if the port or the band is leaking.The initial procedure was performed in (b)(6) 2008 by the surgeon.Fills were performed by the surgeon.There was no patient consequence reported at this time.Device still implanted.

Manufacturer Narrative

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

• 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: 4289886
• MDR Text Key: 5086082
• Report Number: 3005992282-2014-00065
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/02/2014
• 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