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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER PALAXTREME, R50 VEINED, 1000G RESIN, DENTURE, RELINING, REPAIRING, REBASING

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KULZER PALAXTREME, R50 VEINED, 1000G RESIN, DENTURE, RELINING, REPAIRING, REBASING Back to Search Results
Catalog Number 66070975
Device Problem Use of Device Problem (1670)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 08/28/2020
Event Type  Injury  
Manufacturer Narrative

This incident is reportable according to 21 cfr 803. The fda defines this as a serious injury (21 cfr sec. 803. 3) as the office staff reported via (b)(6), kulzer became aware of an allergy case for palaxtreme. 3 dental technicians at 1 laboratory. The employee having an allergic type reaction. This material is not sold in the usa. Kulzer north america distributes a comparable product, where the indications of use are the same, however the chemistry is different. The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

 
Event Description

Allergy suspicion. Via (b)(6) we became aware of an allergy case for palaxtreme. 3 dental technicians at 1 lab.

 
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Brand NamePALAXTREME, R50 VEINED, 1000G
Type of DeviceRESIN, DENTURE, RELINING, REPAIRING, REBASING
Manufacturer (Section D)
KULZER
dietrich honold nr. 1
sacalaz 30737 0
RO 307370
MDR Report Key10575048
MDR Text Key208185638
Report Number1821514-2020-00004
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number66070975
Device LOT NumberK010021
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2020
Device Age1 yr
Event Location Other
Date Report TO Manufacturer09/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/23/2020 Patient Sequence Number: 1
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