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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX AV 1000 S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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ST. WENDEL AG ULTRAFLUX AV 1000 S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 01-8981-0
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  malfunction  
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Brand NameULTRAFLUX AV 1000 S
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
ST. WENDEL AG
fmc deutschland gmbh
frankfurter str. 6-8
st. wendel 66606
GM 66606
Manufacturer (Section G)
ST. WENDEL AG
fmc deutschland gmbh
frankfurter str. 6-8
st. wendel 66606
GM 66606
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14434095
Report Number3002807005-2022-00013
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number01-8981-0
Device Lot NumberB2BA27100
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received05/25/2022
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

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