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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PETER LAZIC GMBH L-ANEURYSM-CLIPS; L-CLIPS MINI TITANIUM TEMPORARY
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PETER LAZIC GMBH L-ANEURYSM-CLIPS; L-CLIPS MINI TITANIUM TEMPORARY Back to Search Results
Model Number 45.22
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2013
Event Type  malfunction  
Event Description
Wrong labeling for l-clip no.45.222.Produces is l-clip no.45.722 - label is documented with 45.222.The clips article no.45.722 and article no.45.222 are in form identical.They are different in color and pressure.Art.No.45.722 has colour pink that means permanent with pressure 110g.Art.No.45.222 has colour pink in front and yellow in the back that means temporary with pressure 70g.Both are titanium clips.
 
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Brand Name
L-ANEURYSM-CLIPS
Type of Device
L-CLIPS MINI TITANIUM TEMPORARY
Manufacturer (Section D)
PETER LAZIC GMBH
immelmannweg 2
tuttlingen D-78 537
GM  D-78537
Manufacturer Contact
immelmannweg 2
tuttlingen 78532
4619664320
MDR Report Key3619012
MDR Text Key4160824
Report Number8010890-2013-00002
Device Sequence Number1
Product Code HCH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Remedial Action Recall
Type of Report Initial
Report Date 11/14/2013
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 Model Number45.22
Device Catalogue Number45.22
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/14/2013
Distributor Facility Aware Date10/23/2003
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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