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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH

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SOPHYSA KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH Back to Search Results
Model Number FVPC4
Device Problem Fracture (1260)
Patient Problems Cerebrospinal Fluid Leakage (1772); Neurological Deficit/Dysfunction (1982)
Event Date 04/05/2020
Event Type  malfunction  
Event Description
When the patient bandage was removed, it was wet and it was observed that the catheter was broken between the patient scalp and the connexion to the drainage system. Catheter was therefore explanted earlier than scheduled. Csf leakage could have led to infection/meningitis and neurological deficiency.
 
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Brand NameKUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
Type of DeviceKUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer (Section G)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer Contact
viviane payrou
5 rue guy moquet
orsay, 91400
FR   91400
MDR Report Key10481137
MDR Text Key206579742
Report Number3001587388-2020-20306
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K853365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFVPC4
Device Catalogue NumberFVPC4
Device Lot Number194693C/STE:G0026
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 Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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