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

Catalog Number RLZB22

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

It was reported that five years ago the pateint received the realize band.Within the first six weeks they had to have a port revision.Last week a ct scan confirmed that the port had repositioned itself once again.

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).Additional information: thank you for contacting me about my realize band that i received on (b)(6) 2009.The lot # is zjkbc4, there are letters above it flzb22 and numbers below it, (b)(4) 2013.Once again, my band was placed on (b)(6) 2009, six weeks after the surgery date, i went for my first fill, i was told the port had flipped.I had a port revision at the same hospital, (b)(6) with the same surgeon in (b)(6) 2009.I was hospitalized on (b)(6) 2014 with abdominal pain until (b)(6).A ct scan was done, at the hospital and i was told the port has relocated itself once again, and the tubing is "kinked." i am scheduled for surgery at my expense on (b)(6) 2014.The band will be removed.

• 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: 4341850
• MDR Text Key: 5175626
• Report Number: 3005992282-2014-00072
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: RLZB22
• Device Lot Number: ZJKBC4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1