MAUDE Adverse Event Report: KULZER GMBH - HQ DIMA PRINT ORTHO; MAINTAINER

Catalog Number 66069096

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

Patient Problem Asthma (1726)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Occured in (b)(6).It has been reported to us that the patient is no longer having any asthmatic episodes.This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) the sales representative was informed by a laboratory that a patient had an asthma episode when using a splint made by our dima print ortho material.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution due to the fact we cannot confirm that the material did or did not cause the asthmatic episode.

Event Description

The incident occured in (b)(6).Kulzer´s sales representative was informed by a dental lab that a patient had an asthma episode when using a splint made of dima print ortho.At this time we cannot determine the causation for the asthma episode nor confirm that the asthma episode was not due to kulzer's dima print ortho material.However, we also cannot eliminate the possibility that our material caused the asthma episode.

• Brand Name: DIMA PRINT ORTHO
• Type of Device: MAINTAINER
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, 63450 ; GM 63450
• MDR Report Key: 8873302
• MDR Text Key: 153667602
• Report Number: 3005665377-2019-00001
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 875.5525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Catalogue Number: 66069096
• Device Lot Number: XG032N01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• 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): Other