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

Catalog Number RLZB32

Device Problem Detachment Of Device Component (1104)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564)

Event Date 03/28/2011

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.(b)(4).

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: we are attempting to determine why the band was removed initially.Was the patient experiencing problems? yes, chronic pain at the port site, nausea, and lack of weight loss.Did the patient present with any symptoms? if so, what were they? pain at port site.Nausea.Surgical findings of extensive adhesions.Has it been determined /confirmed that the patient¿s symptoms are directly related to the realize band? temporally associated with the presence of the band, and the retained plastic tubing strain relief collar which had become loose.Was any test performed to diagnose the issue? fluoroscopy? endoscopy? culture? surgical removal of the band on the second surgery, and removal of the retained plastic tubing strain relief collar on the third surgery.What information did the testing provide? adhesions on the retained plastic tubing strain relief collar.

• Brand Name: REALIZE ADJ GASTRIC BAND
• 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: 4774598
• MDR Text Key: 5953398
• Report Number: 3005992282-2015-00021
• 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,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: RLZB32
• Device Lot Number: ZLLBB6
• Other Device ID Number: 20705036004001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1