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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 531187-32A
Device Problems Kinked (1339); Nonstandard Device (1420); Device Issue (2379); Device-Device Incompatibility (2919); Mechanical Jam (2983)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 01/22/2016
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.
 
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 manufacturing error. If no further information becomes available, file is considered as closed.
 
Event Description
(b)(4). Summarizing translation from user's narrative: catheter did not pass needle smoothly, kinks.
 
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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 Key5446686
MDR Text Key39099765
Report Number9611612-2016-00018
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeAS
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 04/18/2016
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2020
Device Model Number531187-32A
Device Catalogue Number531187-32A
Device Lot Number1110, 1126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
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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