PALAXPRESS LIQUID 64711631

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-03-01 for PALAXPRESS LIQUID 64711631 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[39415992] As allowed by exemption# (b)(4) is submitting the report on behalf of heraeus kulzer (b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Device has not been returned by customer, and the patient is non-compliant. Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10


[39415993] Patient claims to have adverse reaction to temporary denture manufactured with palaxpress liquid.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610902-2016-00006
MDR Report Key5471490
Report SourceCONSUMER
Date Received2016-03-01
Date of Report2016-02-11
Date of Event2016-02-04
Date Facility Aware2016-02-11
Date Mfgr Received2016-02-11
Date Added to Maude2016-03-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. RITA ROGERS
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetPHILIPP-REIS-STRASSE 8/13
Manufacturer CityWEHRHEIM, D-61273
Manufacturer CountryGM
Manufacturer Postal CodeD-61273
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALAXPRESS LIQUID
Generic NameRESIN, DENTURE, RELINING, REPAIRING, REBASING
Product CodeEBI
Date Received2016-03-01
Catalog Number64711631
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressPHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-01

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