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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER, GMBH PALAXPRESS, 500ML LIQUID DENTURE RELINE MATERIAL

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KULZER, GMBH PALAXPRESS, 500ML LIQUID DENTURE RELINE MATERIAL Back to Search Results
Catalog Number 64710513
Device Problem Use of Device Problem (1670)
Patient Problems High Blood Pressure/ Hypertension (1908); Rash (2033); Swelling (2091); Burning Sensation (2146)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative

This patient received relined prosthesis on (b)(6) 2019. The following day, patient started experiencing reddening and stinging sensation of the mouth. The patient immersed the prosthesis in water several times. Patient was seen at a secondary care provider for swelling and reddening of the face, an injection (cortisone?) was given. Symptoms progressed to burning sensation of the tongue and throat. Patient also experienced shortness of breath, high blood pressure, and a burning rash on the patient's body. When symptoms did not subside, patient was admitted to the hospital for observation where an allergy test was ordered. It was determined that the dentist did not immerse the prosthesis in tepid water for at least 12 hours prior to delivery. The dentist only immersed the prosthesis for approximately 3 hours and instructed patient to immerse for 12 hours at home. During follow-up conversation with patient, it was stated that there were no symptoms as long as the prosthesis is not integrated. When the prosthesis is integrated, patient develops symptoms of itching and stinging sensation. Allergy test was performed and the results are negative. Palaxpress was not the cause of the symptoms.

 
Event Description

This event occurred in (b)(6). The patient's prosthesis was relined with palaxpress. When patient received reline back from dentist, patient started experiencing reddening and stinging of the mouth. Patient was seen at a secondary health provider and received an injection (cortisone?) and when symptoms did not subside, patient was hospitalized for observation.

 
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Brand NamePALAXPRESS, 500ML LIQUID
Type of DeviceDENTURE RELINE MATERIAL
Manufacturer (Section D)
KULZER, GMBH
philipp-reis-strabe 8/13
wehrheim, D-612 73
GM D-61273
MDR Report Key8692498
MDR Text Key147771601
Report Number1821514-2019-00007
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation DENTIST
Type of Report Initial
Report Date 06/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue Number64710513
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/15/2019
Event Location Other
Date Report TO Manufacturer06/11/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/12/2019 Patient Sequence Number: 1
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