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

Catalog Number RLZB32

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 05/29/2014

Event Type  Injury  

Event Description

It was reported that they a realize band was implanted in (b)(6), 2009.In (b)(6) of 2014, the patient began having issues with not being able to eat or smell anything without having the feeling that they would throw up.The week of (b)(6), 2014, they went to their doctor and were told that the band had eroded.Per the patient, it had eaten a hole in their stomach.The band was removed on (b)(6) 2014.Immediately after the band was removed, the patient stated they got an infection.Per the patient, they were not released from the doctor¿s care until (b)(6) 2014.

Manufacturer Narrative

(b)(4): information asked for but unknown or not provided during initial contact.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: 4661551
• MDR Text Key: 18627909
• Report Number: 3005992282-2015-00011
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: RLZB32
• Device Lot Number: ZKLBCB
• Other Device ID Number: 20705036004001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1