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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBTECH MEDICAL SARL_
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OBTECH MEDICAL SARL_ Back to Search Results
Catalog Number RLZB32
Device Problem Device Inoperable (1663)
Patient Problems Pain (1994); Surgical procedure, additional (2564)
Event Date 11/01/2011
Event Type  Injury  
Event Description
It was reported that the patient had laparoscopic surgery on (b)(6) 2011 ¿whereupon she was implanted with a realize gastric band bearing the serial number (b)(4)¿.On (b)(6) 2011 patient ¿felt a whipping sensation inside her as a result of her realize gastric band failure¿.And patient suffered severe and excruciating pain and discomfort caused by the realize gastric band¿s failure for 54 weeks and also required an additional bariatric surgery.¿.
 
Manufacturer Narrative
(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.
 
Manufacturer Narrative
(b)(4).
 
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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 Key4305810
MDR Text Key18923602
Report Number3005992282-2014-00067
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberRLZB32
Device Lot NumberZMJBHN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/26/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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