FDA.reportPublic FDA data

MAUDE MDR 2851331

MDR report key
2851331
Report number
9681707-2012-00010
Event key
0
Event type
3
Date of event
2012-09-22
Date received
2012-11-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
AUDI BOGUCKI, RDH
Address
300 HERAEUS WAY SOUTH BEND IN 46614 US
Phone
574-574-5742
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PALAXPRESS ULTRA POWDER AND LIQUIDEBI RESIN, DENTURE, RELINING, REPAIRINGHERAEUS KULZER GMBHEBIPINK66034252012063R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-1901. H

Event Narratives#

D

Patient 1

ON (B)(6) 2012 WE WERE INFORMED THAT PALAXPRESS ULTRA WAS USED TO PRODUCE THE DENTURE FOR A PT. FOURTEEN DAYS AFTER WEARING IT THE PT EXPERIENCED REDNESS AND BLISTERS OF THE MUCOSA. THE DENTURE WAS STORED IN WATER AND THE STATUS OF THE DENTIST IS MONITORING THE PT'S HEALTH. ON (B)(6) 2012 WE WERE INFORMED THAT THE PT WAS REFERRED TO THE HOSPITAL. THE DENTAL LAB STATED THERE IS NO CONNECTION BETWEEN THE DENTURE AND THE REFERRAL TO THE HOSPITAL. ON (B)(6) 2012 HK PRODUCT SAFETY MANAGER SPOKE TO THE DENTIST AND WAS INFORMED THAT THE PT IS BACK AT HOME. THE DENTIST WAS NOT CLEAR IF THE DENTURE AND THE REFERRAL TO THE HOSPITAL ARE CONNECTED. THE PT IS NOW WEARING HER OLD DENTURE. THE DENTIST WILL GET IN TOUCH WITH HKG IF THE PT STATUS WOULD CHANGE/GET WORSE. ON (B)(6) 2012 SAFETY MANAGER SPOKE TO THE DENTIST. THE DENTIST SAID THAT THE COMPLETE MAXILLARY DENTURE MADE OUT OF PALAXPRESS ULTRA WAS DELIVERED TO THE PT IN THE MIDDLE OF (B)(6) 2012. ABOUT ONE WEEK LATER THE PT EXPERIENCED SWELLING OF THE FACE AND INCREASED NUMBER OF LEUKOCYTES. THE PT SPENT A FEW DAYS IN THE HOSPITAL FOR TREATMENT. THE DENTURE WAS WORN UNTIL (B)(6) AND THEN EXCHANGED FOR THE OLD ONE. THE HEALTH SITUATION OF THE PT HAS BEEN IMPROVED SINCE THEN, BUT THE SYMPTOMS HAVE NOT COMPLETELY RESOLVED. THE PT RECEIVES OUT-PATIENT TREATMENT BY SEVERAL DOCTORS, BUT NOT AT THE DENTIST'S OFFICE. THE DENTIST COULD NOT PROVIDE ANY INFO ON THE MEDICAL TREATMENT OF THE PT, BECAUSE HE IS NOT INVOLVED IN THE PROCESS. THE PALAXPRESS ULTRA DENTURE WILL BE REINTRODUCED TO THE PT WHEN THE PT HAS RECOVERED COMPLETELY FROM THE SYMPTOMS. WE WILL CONTINUE TO MONITOR THE PT'S RECOVERY.

N

Patient 1

AS ALLOWED BY (B)(4), (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. CONCLUSION - THE DIRECTIONS FOR USE GIVES THE FOLLOWING WARNING, "PRODUCT CONTAINS POLYMERIZED MONOMERS (E.G. METHACRYLATES/ACRYLATES), WHICH MAY IRRITATE THE SKIN. IF ANY IRRITATION APPEARS OR KNOWN ALLERGIES EXIST WITH RESINS BASED ON METHACRYLATES OR ACRYLATES, THE PRODUCT SHOULD NOT BE USED."