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U.S. Department of Health and Human Services

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

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OBTECH MEDICAL SARL_ SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Catalog Number SAGBX
Device Problems Entrapment of Device (1212); Leak/Splash (1354)
Patient Problem Pain (1994)
Event Date 03/10/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.
 
Event Description
See attached maude event report form #mw5041540.
 
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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-24 00
SZ   CH-2400
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4912619
MDR Text Key22388959
Report Number3005992282-2015-00034
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Report Date 06/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSAGBX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/14/2015
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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