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

Catalog Number RLZB32

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Discomfort (2330)

Event Date 05/22/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a realize band was removed and converted to a gastric sleeve on (b)(6) 2013 she experienced pain and pulling on her left side.She originally had the band placed in (b)(6) of 2011.The patient had exploratory surgery on (b)(6) 2014 for the pain and it was found that a piece of the realize band had been left inside of her.After the piece was removed she no longer had any pain or pulling.No device will be returned.The surgeon who performed the removal/conversion procedure was the same surgeon who performed the exploratory surgery, but not the surgeon who originally implanted the band.

Manufacturer Narrative

(b)(4).A review of the photography was performed by a cross functional team, however it was not possible to establish the presence of a piece of the gastric band.It was concluded that photograph does not provided enough details therefore, no conclusion: device was not returned for evaluation.

• 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5670962
• MDR Text Key: 45660132
• Report Number: 3005992282-2016-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

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: 05/06/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1