• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG SONO CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT Back to Search Results
Model Number 531187-31A
Device Problems Fracture (1260); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (b)(4). 2 lot were reported: 1216
=
(b)(6) 2017 (mfr. ). 1222
=
(b)(6) 2017 (mfr. ) based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
Irn# (b)(4). Tentative translation and summary of initial reporter narrative: rupture - fragment remains with patient.
 
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6) - pajunk medical produkte (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 translation and summary of initial reporter's narrative: rupture - fragment remains with patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSONOLONG SONO
Type of DeviceCONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING 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
geisingen, baden-wuerttemberg 78187
GM   78187
MDR Report Key7098937
MDR Text Key262701900
Report Number9611612-2017-00016
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 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number531187-31A
Device Catalogue Number531187-31A
Device Lot Number1216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/10/2017
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: 12/08/2017 Patient Sequence Number: 1
-
-