PALAXPRESS 64710513

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-16 for PALAXPRESS 64710513 manufactured by Kulzer Gmbh.

MAUDE Entry Details

Report Number1821514-2019-00008
MDR Report Key8795390
Date Received2019-07-16
Date of Report2019-07-16
Date of Event2019-06-18
Date Facility Aware2019-06-25
Date Added to Maude2019-07-16
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALAXPRESS
Generic NameDENTURE ACRYLIC
Product CodeEBI
Date Received2019-07-16
Catalog Number64710513
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKULZER GMBH
Manufacturer AddressPHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-16

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