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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO PERIPHERAL NERVE BLOCK KIT

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PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO PERIPHERAL NERVE BLOCK KIT Back to Search Results
Model Number 521185-31A
Device Problems Partial Blockage (1065); Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2016
Event Type  malfunction  
Manufacturer Narrative
(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 summarizing translation from user's narrative: catheter cannot be rinsed, no passage.
 
Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
 
Event Description
(b)(4). Tentative summarizing translation from user´s narrative: catheter cannot be rinsed, no passage.
 
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Brand NameSONOLONG ECHO
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 Key5828437
MDR Text Key51506354
Report Number9611612-2016-00105
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Model Number521185-31A
Device Catalogue Number521185-31A
Device Lot Number1154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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: 07/28/2016 Patient Sequence Number: 1
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