MAUDE Adverse Event Report: KULZER GMBH - HQ PROVIL NOVO L.; MATERIAL, IMPRESSION

Catalog Number 65209225

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's view: swallowing of impression material in minor amounts is a daily impression procedure issue.This is happening million folds without any severe digest consequences.The probability is less than one incident per 1.000.000 million impression takings.And in severe cases considerable amounts were swallowed.Therefore, it is a common minor risk of impression procedure with a very small incident rate of a severe outcome.In this it was confirmed that only 1 to 2 ml were swallowed without medical consequences.

Event Description

Patient swallowed 1 - 2 ml of the uncured provil novo light.She has had no symptoms.Patient is in their 70s.Woman.Occurred while taking an impression using provil novo l.Patient's subjective symptom = no particular.Amount swallowed = very small amount (1 ~ 2ml).The impression material flowed a little in an uncured state, but the process was completed successfully.Since the amount swallowed is extremely small, it is highly likely that it will be excreted as stool, but we cannot diagnose it, so we asked for follow-up.The next medical examination day will be wednesday, november 4th.No symptoms and injury finally reported to manufacture despite several inquiries - no serious injury finally reported until date of this report.

• Brand Name: PROVIL NOVO L.
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): KULZER GMBH - HQ; 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: 10875176
• MDR Text Key: 217331839
• Report Number: 3005665377-2020-00006
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973694
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 65209225
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• 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