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

Catalog Number 66043319

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Ulceration (2116)

Event Type  Injury  

Event Description

Heraeus kulzer (b)(4) reports potential allergic reaction two years after dentures were manufactured using (b)(4).Laboratory of solta-dent dental laboratory has obtained the exact composition of our product of palaxpress.After sending (b)(4) has asked for recall with the zap (b)(4).In the phone call with (b)(4) turned out, that patient has a reaction to their uk and ok - prosthesis.It highlights mucosal changes - white ich, red sores.The dentures were made in the years 2012 - since then the positions are available.After a lining of the uk - prosthesis in may of this year with palaxpress clear these places have disappeared.The ok - graft next year should also be colorless relined.I told the customer to refer the patient to an allergist before they relined the ok or to keep me on this case on the current.If it's allergy only color pigments can be the trigger.This incident occurred in (b)(6).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.Report to fda due to product being substantially equivalent to product available for purchase 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.Device not returned to manufacturer.

• Brand Name: PALXPRESS
• 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 GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4414114
• MDR Text Key: 5372671
• Report Number: 9610902-2015-00001
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 66043319
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/08/2015
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other