MAUDE Adverse Event Report: KULZER GMBH PALAXPRESS; DENTURE BASE MATERIAL

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.

• Brand Name: PALAXPRESS
• Type of Device: DENTURE 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 Key: 8694938
• MDR Text Key: 147853053
• Report Number: 9610902-2019-00007
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K902115
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 64710513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/13/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR