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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

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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 Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Batch # unk.
 
Event Description
It was reported from a customer the patient has not been subjected to port replacement, but the opening / closing system is proving to be ineffective.There are no other details available at this time.
 
Manufacturer Narrative
(b)(4).
 
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.
 
Manufacturer Narrative
(b)(4).
 
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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
kathy rice
4545 creek rd
cincinnati, OH 45242-2803
5133373299
MDR Report Key5680738
MDR Text Key46018553
Report Number3005992282-2016-00012
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,Followup,Followup
Report Date 11/26/2010
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 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 05/25/2016
Initial Date FDA Received05/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received05/31/2016
05/31/2016
06/06/2016
06/07/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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