MAUDE Adverse Event Report: HERAEUS KULZER GMBH PALAXPRESS LIQUID 80ML; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number 64711631

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

Patient Problems Nausea (1970); Burning Sensation (2146); Reaction (2414)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).From directions for use: contraindication.Direct lining with palaxpress is contraindicated.If the patient is allergic to one or more ingredients of palaxpress, the product must not be used.To further reduce the risk of intolerance, heraeus kulzer recommends always immersing prostheses (both new and repaired) in tepid water for at least 12 hours before placement.(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.Narrative: device has not been returned by customer, and the patient is non-compliant.Product was not returned to manufacturer.

Event Description

A dental technician applied palaxpress liquid monomer directly into the patient's mouth.The patient experienced burning feeling, had shortness of breath and vomiting.

• Brand Name: PALAXPRESS LIQUID 80ML
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5787765
• MDR Text Key: 49367827
• Report Number: 9610902-2016-00011
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K902115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64711631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/23/2016
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention