DOVAC ELITE V2.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for DOVAC ELITE V2.0 manufactured by It Synergistics, Llc.

Event Text Entries

[24148667] Refer to attached report for investigation and corrective action.
Patient Sequence No: 1, Text Type: N, H10


[24148768] The dovac elite v2. 0 system allowed the technician review process to be completed for a full length donor history questionnaire (dhq) without obtaining a response for a single question. Refer to the attached report beginning on page 4 for a complete investigation and corrective action completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435501-2015-00001
MDR Report Key5004152
Date Received2015-08-12
Date of Report2015-08-07
Date of Event2015-07-15
Date Mfgr Received2015-07-15
Device Manufacturer Date2014-04-09
Date Added to Maude2015-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKALMAN GROF-TISZA
Manufacturer Street115 TREE ST
Manufacturer CityFLOWOOD MS 39232
Manufacturer CountryUS
Manufacturer Postal39232
Manufacturer Phone8558667648
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDOVAC ELITE V2.0
Generic NameDOVAC ELITE V2.0
Product CodeMMH
Date Received2015-08-12
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID Number5
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIT SYNERGISTICS, LLC
Manufacturer AddressFLOWOOD MS US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-12

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