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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 521157-32A
Device Problems Partial Blockage (1065); Disconnection (1171); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Device Handling Problem (3265)
Patient Problems Foreign Body In Patient (2687); No Information (3190)
Event Date 11/17/2016
Event Type  malfunction  
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: disconnection of the electric wire. The electric wire is blocked at the catheter support (container?).
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Initial reporter´s narrative: disconnection of the electric wire. The electric wire is blocked at the catheter support (container?).
 
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Brand NameSTIMULONG SONO
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 Key6150242
MDR Text Key62147517
Report Number9611612-2016-00152
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/01/2021
Device Model Number521157-32A
Device Catalogue Number521157-32A
Device Lot Number1166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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: 12/07/2016 Patient Sequence Number: 1
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