• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY Back to Search Results
Catalog Number BD3XV
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Erosion (1750)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional information received: migration of gastric band due to vomiting, gastroenteritis, band removed.
 
Event Description
It was reported that the patient have received at least one port replacement and are in observation.There are no other details available at this time.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed by the customer quality engineer on the 06 june 2016, and no discrepancies were recorded during the manufacturing process in relation to the alleged issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
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 Key5680975
MDR Text Key45962955
Report Number3005992282-2016-00021
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/25/2016
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 NumberBD3XV
Device Lot Number20217032
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/25/2016
Initial Date FDA Received05/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/31/2016
06/06/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2009
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
-
-