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U.S. Department of Health and Human Services

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

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OBTECH MEDICAL SARL_ REALIZE GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Catalog Number RLZB22
Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 07/31/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent: 9/28/2016.Batch # asku.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is a lot number available? are there plans to remove the piece remaining in the abdomen? is a copy of the scan available for review?.
 
Event Description
It was reported by the patient that post implant of the realize band, the band slipped and the band was removed.The patient reported having a laparoscopic gastric bypass.On (b)(6) 2016, an elongated lump, approximately three centimeters long, appeared in the patient's stomach area.The patient stated that an ultrasound and ct with contrast performed and the tests showed an unknown part of the original realize band was still implanted in the patient.The patient has an appointment with the original surgeon who implanted the realize band on (b)(6) 2016.The patient indicated there was no pain.
 
Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: per the patient the object remaining inside is approximately 3 inches.
 
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Brand Name
REALIZE GASTRIC BAND
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 Key5983302
MDR Text Key55814085
Report Number3005992282-2016-00042
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
Type of Report Initial,Followup
Report Date 09/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberRLZB22
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/07/2016
Initial Date FDA Received09/28/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/18/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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