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

Catalog Number RLZB32

Device Problem Insufficient Information (3190)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Discomfort (2330); Surgical procedure, additional (2564)

Event Date 06/11/2014

Event Type  Injury  

Event Description

It was reported by the customer that patient had a realize band placed on (b)(6) 2010.The patient began to experience pain and discomfort in the left upper quadrant of her abdomen since (b)(6) 2013.The patient later began to experience difficulty breathing that was progressively getting worse.The port was closely aligned to the patient's rib muscle and was causing the patient to have difficulty breathing.The port has been removed and the patient symptoms have resolved.The plan is to remove the band at a later date as there is no plan to implant a new port.At this time there is no known issue with the band.

Manufacturer Narrative

(b)(4).Information was not provided by contact.Information unavailable.

Manufacturer Narrative

(b)(4).Upon further view of the event by the medical director, at this time there is no known issue with the band.Placement of the port is a surgeon decision,and is not device related event.Removing it was for subjective relief of pain, and not to prevent permanent impairment.It was concluded that this event does not meet the fda defined criteria of a serious injury.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• 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: 3927784
• MDR Text Key: 21998912
• Report Number: 3005992282-2014-00038
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Device Lot Number: ZLKBBN
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 198