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U.S. Department of Health and Human Services

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

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 531187-31A
Device Problems Device Or Device Fragments Location Unknown (2590); Device Handling Problem (3265)
Patient Problems Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165)
Event Date 01/14/2016
Event Type  malfunction  
Manufacturer Narrative
Event took place in (b)(6) and has not been reported to national health authorities. We consider this file as closed.
 
Event Description
(b)(4). Summarizing translation of user's/reporters narrative: suddenly catheter broke without overburdening.
 
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Brand NameSONOLONG 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 Key5503649
MDR Text Key40408332
Report Number9611612-2016-00033
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
Report Date 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2020
Device Model Number531187-31A
Device Catalogue Number531187-31A
Device Lot Number1139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
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: 03/16/2016 Patient Sequence Number: 1
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