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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERAEUS KULZER GMBH PALAXPRESS LIQUID RESIN, DENTURE, RELINING, REPAIRING, REBASING

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HERAEUS KULZER GMBH PALAXPRESS LIQUID RESIN, DENTURE, RELINING, REPAIRING, REBASING Back to Search Results
Catalog Number 64711631
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Complaint, Ill-Defined (2331)
Event Date 02/04/2016
Event Type  Injury  
Manufacturer Narrative

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.

 
Event Description

Patient claims to have adverse reaction to temporary denture manufactured with palaxpress liquid.

 
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Brand NamePALAXPRESS LIQUID
Type of DeviceRESIN, DENTURE, RELINING, REPAIRING, REBASING
Manufacturer (Section D)
HERAEUS KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, D-612 73
GM D-61273
Manufacturer (Section G)
HERAEUS KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, D-612 73
GM D-61273
Manufacturer Contact
rita rogers
300 heraeus way
south bend, IN 46614
5742995409
MDR Report Key5471490
MDR Text Key39415992
Report Number9610902-2016-00006
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK902115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator DENTIST
Device Catalogue Number64711631
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/11/2016
Event Location No Information
Date Manufacturer Received02/11/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/01/2016 Patient Sequence Number: 1
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