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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG NANOLINE CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT Back to Search Results
Model Number NOT AVAILABLE
Device Problems Fracture (1260); Material Integrity Problem (2978); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/08/2017
Event Type  Injury  
Manufacturer Narrative
Item number and manufacturing lot can neither be identified nor reconstructed. Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
Irn# (b)(4). Initial reporter´s narrative: stimulation wire came out of catheter tube.
 
Manufacturer Narrative
Currently the data is poor and the device has not been sent back/ analysed. As soon as further data will be available, a follow up report will be sent in to the agency.
 
Event Description
(b)(4). Initial reporter´s narrative: stimulation wire came out of catheter tube.
 
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Brand NameSTIMULONG NANOLINE
Type of DeviceCONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING 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
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7098952
MDR Text Key258921759
Report Number9611612-2017-00017
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043130
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 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNOT AVAILABLE
Device Catalogue NumberNOT REPORTET
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
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: 12/08/2017 Patient Sequence Number: 1
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