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

Catalog Number 66002186

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Dentist needs to be informed by the patient if there are complications like problems with stomach, intestines, or digestion.It is possible (and we hope) that the material will come out the 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 the (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 SRL; dietch honold 1; claderia c3; sacalaz-judetul, 30737 0; RO 307370
• MDR Report Key: 8688662
• MDR Text Key: 147650486
• Report Number: 1821514-2019-00006
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2019
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other