MAUDE Adverse Event Report: KULZER GMBH - HQ FLEXITIME LIGHT FLOW; IMPRESSION MATERIAL

Catalog Number 40005040

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

Patient Problem Discomfort (2330)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury(21 cfr sec.803.3) this incident came to our attention via kulzer sales rep who stated the office contacted her asking if the impression material was radiopaque as they had a patient where some may have been swallowed.Flexitime impression material is not radiopaque, and this information was relayed to the office.The patient went to the emergency room where an exam was performed and xrays taken.No treatment recommended by radiologist.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.On 9/14/2020, i sent email response with dr.M cc'd stating that our material is not radiopaque and that i would be following up the next day.On 9/15/2020, left message with office asking for (b)(6) to call back regarding patient who swallowed impression material.On 9/15/2020, (b)(6) called from(b)(6) location, where the incident took place.(b)(6) let me know they were using flexitime light flow as a wash in denture, and the patient (female) gagged and they immediately gave her suction, but the patient felt that she had swallowed some.They did not see if some was actually swallowed as they suctioned out the material.They were worried about a possible bowel blockage, and the patient went to the er right after the appointment.Xrays were taken and examination performed and nothing was seen on the xray.I did let doctor know our impression material does not have radio-opacity and that an xray would likely not show swallowed material.She said they took some of the material and let it set and then took an xray of it and it showed up.I explained that we would still stand by that it is not radiopaque and would not show up on xray.The patient was discharged, and the radiologist called and spoke with dr.D stating everything seemed ok.They will follow up with patient and i will follow up with them in a week.I did recommend for them to contact patient regularly to see if any digestive problems arise, gastric discomfort, acid reflux, and to check stool for colored content.On 9/22/2020, i spoke with front office who stated they checked in with patient, and she is feeling fine.She had what she described as cramping a couple days after the incident, but had a bowel movement and after that she felt normal and has felt fine since.She did not see any foreign material or abnormal color in her stool.Office staff stated they did not receive any paperwork from hospital or patient, just verbal phone conversation the doctor had with the radiologist.On 11/13/2020, due to technical issues with e-submitter and webtrader access, kulzer is only able to report that issue late.Nevertheless the importer has already reported in time and swallowing of impression material in minor amounts is a daily 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 case there was no severe injury except for the additional, useless imaging procedure by x-ray.

Event Description

Patient gagged while having a procedure done, and accidentally swallowed a small amount of impression material.

• Brand Name: FLEXITIME LIGHT FLOW
• Type of Device: IMPRESSION MATERIAL
• 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: 10835346
• MDR Text Key: 217935158
• Report Number: 3005665377-2020-00004
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: 40005040
• Device Lot Number: K010115
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• 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