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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER GMBH PALAXPRESS DENTURE BASE MATERIAL

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KULZER GMBH PALAXPRESS DENTURE BASE MATERIAL Back to Search Results
Catalog Number 64710513
Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problems High Blood Pressure/ Hypertension (1908); Rash (2033); Swelling (2091); Burning Sensation (2146)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative

An allergy test was performed to identify palaxpress as allergen to the patient. The result was that patient does not react to ingredients of the product. The allergy allegation could not be verified. The patient has a lot of medical issues and takes a lot of different drugs and therefore, a psychosomatic reaction in combination with the relining of the prosthesis cannot be excluded. Kulzer (b)(4) reports this incident out of caution to be compliant with 21 cfr 803 and out of abundance of caution.

 
Event Description

The patient's prosthesis was relined with palaxpress. When patient received relined prosthesis back from dentist, patient started experiencing redding and stinging of mouth. Patient went to a second healthcare provider and received an injection (cortisone?). As symptoms did not subside, patient was hospitalised for observation during four days.

 
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Brand NamePALAXPRESS
Type of DeviceDENTURE BASE MATERIAL
Manufacturer (Section D)
KULZER GMBH
leipziger strasse 2
hanau, hesse 63450
GM 63450
Manufacturer (Section G)
KULZER GMBH - WEHRHEIM
philipp-reis-strasse 8/13
wehrheim, hesse 61273
GM 61273
Manufacturer Contact
albert erdrich
leipziger strasse 2
hanau, hesse 63450
GM   63450
MDR Report Key8694938
MDR Text Key147853053
Report Number9610902-2019-00007
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK902115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation DENTIST
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 06/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue Number64710513
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/13/2019 Patient Sequence Number: 1
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