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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERAEUS KULZER GMBH PALAXPRESS, PINK, 1000G POWDER RESIN, DENTURE, RELINING, REPAIRING, REBASING

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HERAEUS KULZER GMBH PALAXPRESS, PINK, 1000G POWDER RESIN, DENTURE, RELINING, REPAIRING, REBASING Back to Search Results
Catalog Number 64710515
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Complaint, Ill-Defined (2331)
Event Type  Injury  
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. Narrative for method/results/conclusion codes, device has not been returned by customer, lot number not provided. Device not returned.

 
Event Description

The occurred in (b)(6). Lab reports three patients experiencing mucosal redness after prosthetic treament with palaxpress. The lab technicians do not measure, but mix freehand.

 
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Brand NamePALAXPRESS, PINK, 1000G POWDER
Type of DeviceRESIN, 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 Key5408240
MDR Text Key37425483
Report Number9610902-2016-00003
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK902115
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER HEALTH CARE PROFESSIONAL
Device Catalogue Number64710515
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/08/2016
Event Location No Information
Date Manufacturer Received01/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/03/2016 Patient Sequence Number: 1
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