• 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 EPILONG TUOHY KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA AND ANALGESIA

  • 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 EPILONG TUOHY KIT FOR CONTINUOUS EPIDURAL ANAESTHESIA AND ANALGESIA Back to Search Results
Model Number 0531152-51
Device Problem Fracture (1260)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 08/03/2018
Event Type  Injury  
Manufacturer Narrative
Event took place in (b)(6) and has been reported through (b)(6). 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). Catheter torn apart, required intervention to remove fragment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEPILONG TUOHY
Type of DeviceKIT FOR CONTINUOUS EPIDURAL ANAESTHESIA AND ANALGESIA
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 Key7808035
MDR Text Key117959075
Report Number9611612-2018-00030
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K060311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/12/2018
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? No
Device Operator
Device Model Number0531152-51
Device Catalogue Number0531152-51
Device Lot Number1227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/23/2018 Patient Sequence Number: 1
-
-