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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO CONTINUOUS PERIPHERAL ANAESTHESIA, KIT, ECHOGENIC, STIMULATION (DUAL GUIDANCE)

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO CONTINUOUS PERIPHERAL ANAESTHESIA, KIT, ECHOGENIC, STIMULATION (DUAL GUIDANCE) Back to Search Results
Model Number 521187-31B
Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
Event took place in austria and has been reported through german distribution subsidiary pajunk medical produkte (b)(4). Currently the data is poor and the device has not been returned/ analysed. As soon as further data will be available a follow up report will be sent in to the agency.
 
Event Description
(b)(4). Inner coil got loosened within patient; had to be surgically removed.
 
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Brand NameSONOLONG SONO
Type of DeviceCONTINUOUS PERIPHERAL ANAESTHESIA, KIT, ECHOGENIC, STIMULATION (DUAL GUIDANCE)
Manufacturer (Section D)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
tuttlinger str. 7
geisingen, baden-wuerttemberg 78187
GM 78187
Manufacturer (Section G)
PAJUNK GMBH MEDIZINTECHNOLOGIE
karl-hall-str. 1
tuttlinger str. 7
geisingen, baden-wuerttemberg 78187
GM 78187
Manufacturer Contact
christian quass
karl-hall-str. 1
tuttlinger str. 7
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7808037
MDR Text Key117961115
Report Number9611612-2018-00032
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K113188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number521187-31B
Device Catalogue Number521187-31B
Device Lot Number1216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2017
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: 08/23/2018 Patient Sequence Number: 1
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