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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 531185-31A
Device Problems Kinked (1339); Nonstandard Device (1420); Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problems Awareness during Anaesthesia (1707); No Information (3190)
Event Date 01/15/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6). At this time information on the device and the incident is poor. No information about the device´s whereabout. Follow up will be sent as soon as more information becomes available. Not returned.
 
Event Description
(b)(4). Users narrative tentative translation: catheter does not go smoothly through needle, kinks.
 
Manufacturer Narrative
Event took place in (b)(6). Isolated event. File is considered as closed.
 
Event Description
Internal report number: (b)(4). Users narrative tentative translation: catheter does not go smoothly through needle, kinks.
 
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Brand NameSONOLONG ECHO
Type of DevicePERIPHERAL NERVE BLOCK KIT
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM 78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
geisingen, baden-wuerttemberg 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
regulatory & safety affairs
geisingen, baden-wuerttemberg 78187
GM   78187
7704929158
MDR Report Key5446648
MDR Text Key39039179
Report Number9611612-2016-00017
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2017
Device Model Number531185-31A
Device Catalogue Number531185-31A
Device Lot Number984
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2016 Patient Sequence Number: 1
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