MAUDE Adverse Event Report: HERAEUS KULZER GMBH PALADUR PINK; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number 64707945

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 12/01/2014

Event Type  Injury  

Event Description

This incident occurred in (b)(6).Reporting technical service: (b)(6).(b)(6) 2014: telescope prosthesis produced with paladur (patient free of complaints).End of 2014: first of three repairs with paladur were performed and afflictions of the patient began (mucosa irritation of the throat, burning sensation on the tongue).2015: an allergy test was accomplished: with no result concerning paladur but with an adverse reaction to a so called allergy-free compound sinomer (used due to a good experience of the dental lab with this product).Further planned measure is to remove paladur as far as possible and to replace the base material by paladon.Patient has never seen an allergist.Obviously, a dental technician did this "allergy testing" on its own; he did this test to compare paladur with sinomer (novodent - methyl methacrylate free product).By now the patient's afflictions and the causation for them are still unclear and further information has to be required from the lab and a regular allergy test is recommended.We recommended to work together with an allergist and will send the compound information if a contact is given.Additionally, an alloy allergy should be considered as it is a telescopic work with metal parts which could be the cause for the symptoms, too (see negative result of the unqualified allergy testing).This is reportable according to 21 cfr 803.There is an allegation of serious injury as defined in part 803.3.The patient involved is investigating a potential allergic reaction.No accusation or proof has been given that this device caused or contributed to the patients symptoms.Out of an abundance of caution we will report this incident.Although this exact product is not available in north america, it is substantially equivalent to palapress and palaxpress which are available in north america.

Manufacturer Narrative

(b)(4).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Method/results/conclusion: device has not been returned by customer.

• Brand Name: PALADUR PINK
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 251
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4630195
• MDR Text Key: 21082195
• Report Number: 9610902-2015-00006
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 64707945
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/06/2015
• Date Manufacturer Received: 03/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other