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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE RECTUS SHEATH BLOCK KIT PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE RECTUS SHEATH BLOCK KIT PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 0721153-49
Device Problems Break (1069); Device Handling Problem (3265)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
Currently the data is poor (neither lot nor details are known) 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). Summarizing narrative from initial reporter: the catheter was surgical inserted and when removed the last 1. 5 cms sheared off and was left in the patient.
 
Manufacturer Narrative
Currently, the data is poor (neither lot nor details are known) 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. Based on risk assessment and clinical evaluation file is considered as closed. Device not returned.
 
Event Description
(b)(4). Summarizing narrative from initial reporter: the catheter was surgical inserted and when removed the last 1. 5cms sheared off and was left in the patient.
 
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Brand NameRECTUS SHEATH BLOCK KIT
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 Key6150240
MDR Text Key61596366
Report Number9611612-2016-00151
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0721153-49
Device Catalogue Number0721153-49
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
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 Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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