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

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.

• Brand Name: PALAXPRESS, PINK, 1000G POWDER
• 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: 5408240
• MDR Text Key: 37425483
• Report Number: 9610902-2016-00003
• 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: 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 Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 64710515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/08/2016
• Date Manufacturer Received: 01/08/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other