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

Catalog Number 64707870

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Burning Sensation (2146); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This occurred in (b)(6).(b)(4).This is a reportable malfunction according to 21 cfr 803.50 (a) (2) which states that you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.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.Device has not been returned by customer.Device was not returned to manufacturer.

Event Description

This occurred in (b)(6).Conversation with lab: patient with known benzoyl peroxide allergy had burning and redness since 2013 under denture made with palapress vario.

• Brand Name: PALAPRESS VARIO, PINK
• 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, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5303607
• MDR Text Key: 33699442
• Report Number: 9610902-2015-00019
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 64707870
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/09/2015
• Date Manufacturer Received: 11/20/2015
• 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