MAUDE Adverse Event Report: KULZER GMBH DIMA PRINT ORTHO; MAINTAINER, SPACE PREFORMED, ORTHODONTIC

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

Incident occured in (b)(6).Was informed by laboratory that a patient had an asthma episode when using a splint made with kulzer dima print ortho material.At this time we cannot determine causation or confirm the asthma episode was due to dima print ortho material.However, we also cannot eliminate the possibility that our material did not cause the asthma episode.

• Brand Name: DIMA PRINT ORTHO
• Type of Device: MAINTAINER, SPACE PREFORMED, ORTHODONTIC
• Manufacturer (Section D): KULZER GMBH; leipziger strabe 2; hanau, 63450 ; GM 63450
• MDR Report Key: 8871394
• MDR Text Key: 153971585
• Report Number: 1821514-2019-00011
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/07/2019,08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2019
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other