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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 531157-32A
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Handling Problem (3265)
Patient Problems Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 05/19/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4). 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). Tentative summarizing translation of initial reporter's narrative: upon advancement catheter kinks, hard to inject via kinked catheter, upon removal catheter tears apart, unable to handle this type of catheter.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Tentative summarizing translation of initial reporter´s narrative: upon advancement catheter kinks, hard to inject via kinked catheter, upon removal catheter tears apart, unable to handle this type of catheter.
 
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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 Key5688234
MDR Text Key46176947
Report Number9611612-2016-00074
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 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Model Number531157-32A
Device Catalogue Number531157-32A
Device Lot Number1153
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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: 05/31/2016 Patient Sequence Number: 1
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