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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Catalog Number RLZB32
Device Problems Disconnection (1171); Appropriate Term/Code Not Available (3191)
Patient Problem Surgical procedure, additional (2564)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
It was reported that the patient had a realize band placed in 2010.The patient began to experience port site pain and was evaluated by her physician.It was determined that the port connection tubing came off of the band and was free floating in abdomen.The patient was re-operated on today for explant of band and to have gastric sleeve procedure performed as patient was not compliant with realize band.
 
Manufacturer Narrative
(b)(4): information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.
 
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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 Key4270276
MDR Text Key5301018
Report Number3005992282-2014-00064
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRLZB32
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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