MAUDE Adverse Event Report: KULZER GMBH FLEXITIME CORRECT FLOW; IMPRESSION MATERIAL

Catalog Number 66002186

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Dentist needs to be informed by the patient if there are complications like problems with stomach, intestines, or digestion.It is expected that the material will leave the patient on a natural way.The patient should look at bowel movement.If she recognizes the green correct flow, everything will be fine/ok.If there occur problems, like pain, problems with digestion or something else, the patient should go to a clinic to do a stomach-intestines reflection.This, because the material could be a reason for a blockage in the stomach-intestines tract.On (b)(6) 2019, we got the feedback from the dental surgery that the piece was found in the stool.The patient did not experience any trouble and is doing fine.

Event Description

This occurred in (b)(6).Dentist made an impression of the upper jaw, region 27, with flexitime correct flow.The patient swallowed a bit of the material, in the size of a pea/hazelnut.Dentist has been informed that he should keep close contact for the upcoming weeks (3-4) and keep asking/up to date about the status of the patient.

• Brand Name: FLEXITIME CORRECT FLOW
• Type of Device: IMPRESSION MATERIAL
• Manufacturer (Section D): KULZER GMBH; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• Manufacturer (Section G): KULZER SRL; dietrich honold 1; claderia c3; sacalaz-judetul, timisoara 30737 0; RO 307370
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 8694936
• MDR Text Key: 149799895
• Report Number: 3011203516-2019-00001
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/29/2021
• Device Catalogue Number: 66002186
• Device Lot Number: K010108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• 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