MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB WITH VELOCITY INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Insufficient Information (3190)

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

Event Date 10/30/2013

Event Type  Injury  

Event Description

It was reported that there was a removal of the gastric band and subcutaneous port due to regurgitation.The patient is okay.The event was resolved without consequence to the patient.

Manufacturer Narrative

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

• Brand Name: SAGB WITH VELOCITY INJECTION PORT
• 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: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 4536927
• MDR Text Key: 5352981
• Report Number: 3005992282-2015-00007
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 63 YR