MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE INJECTION PORT AND APP; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZPT2

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 09/15/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The following information was requested, but unavailable: was a port applier used to anchor the port? were sutures used when anchoring the port? were the injection port hooks: partially retracted/deployed

Event Description

It was reported that post-op from a laparoscopic insertion of adjustable realize c band procedure that was (b)(6) 2014.There was an issue with the attachment port.An adjustment was tried under fluoroscopy and it was seen that the port was detached from the abdominal wall.The port itself was intact.

• Brand Name: REALIZE INJECTION PORT AND APP
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-2 400; 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: 4912721
• MDR Text Key: 22388259
• Report Number: 3005992282-2015-00035
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZPT2
• Device Lot Number: ASKU
• Other Device ID Number: 20705036004018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• 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