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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; WOUND INFILTRATION CATHETER KIT
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PAJUNK GMBH MEDIZINTECHNOLOGIE INFILTRALONG; WOUND INFILTRATION CATHETER KIT Back to Search Results
Model Number 001158-30C
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 08/12/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Currently the data is poor, the case is rather old 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).Initial reporter´s narrative: catheter snapped off at point where it inserts into filter.
 
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Brand Name
INFILTRALONG
Type of Device
WOUND INFILTRATION CATHETER 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 Key7098960
MDR Text Key95066798
Report Number9611612-2017-00018
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K080675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/08/2017
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? Yes
Device Operator Physician
Device Model Number001158-30C
Device Catalogue Number001158-30C
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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