PALAPRESS VARIO PINK VEINED 64707891

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-06 for PALAPRESS VARIO PINK VEINED 64707891 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[3805345] The dentist reported an allergic reaction to palapress vario. After delivering to the patient a new full upper denture and a partial lower denture, the patient returned on the incident day to the dental office complaining about problems when swallowing, inflammation in and around the mouth, the corners of the mouth and on the face as well as about burning tongue. The dentist found that the mucosa and the lymph nodes of the patient were swollen. There is redness at the corners of the mouth with inflammation lines continuing to wrinkle down to the chin, a swollen tongue and a rash with red blisters under the lower lip down to the chin. Initially we were informed about choking fits but this could not be verified with the dentist when calling him. The dentist took back the new denture and replaced with the previous one. He delivered the new ones back to the denture lab and asked to decoct them or to leach them out with warm water. Over the weekend the patient used the old dentures and his symptoms improved the rhagades at the corners of the patient's mouth returned. The dentist returned the reprocessed denture to the patient ((b)(6) 2013) and by the end of the week the patient noticed the return of the discomfort ((b)(6) 2013) so he usee the old dentures again and has no problems ((b)(6) 2013). Dr (b)(6), is a bio-dentist using alternative methods, he is specialized on bio-resonance methodology. He tested the patient after he developed the symptoms with this method and found out that the powder and the liquid as well as final denture are unsuitable for this patient. It is necessary to use for this patient a methyl-methacrylate free. He did not confirm an allergic reaction but he is also reluctant to send the patient to a dermatologist for an allergy test ((b)(6) 2013). (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1925223-2013-00124
• MDR Report Key: 3342112
• Date Received: 2013-09-06
• Date of Report: 2013-08-08
• Date of Event: 2013-08-07
• Date Facility Aware: 2013-08-16
• Date Added to Maude: 2013-09-12
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 4315 SOUTH LAFAYETTE BLVD.
• Manufacturer City: SOUTH BEND IN 466142517
• Manufacturer Country: US
• Manufacturer Postal: 466142517
• Manufacturer G1: HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
• Manufacturer Street: 4315 SOUTH LAFAYETTE BLVD.
• Manufacturer City: SOUTH BEND IN 46614251
• Manufacturer Country: US
• Manufacturer Postal Code: 46614 2517
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PALAPRESS VARIO
• Generic Name: EBI RESIN, DENTURE, RELINING, REPAIRING
• Product Code: EBI
• Date Received: 2013-09-06
• Model Number: PINK VEINED
• Catalog Number: 64707891
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HERAEUS KULZER GMBH
• Manufacturer Address: WEHRHEIM GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-09-06