MAUDE Adverse Event Report: KULZER GMBH - HQ FLEXITIME LIGHT FLOW 1 X (2 X 50 ML); MATERIAL, IMPRESSION

Catalog Number	40005040
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was reported to have an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products.
Additional Manufacturer Narrative
This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury(21 cfr sec.803.3) as the office staff reported the patient having an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products, one of which was a kulzer product, that required administration of benadryl by doctor.Symptoms resolved 2 hours after treatment.Allergy testing was stated to have been completed, but results have not been provided to the dental office at this time.Ifu states, "this product or one of its components may in particular cases cause hypersensitive reactions.The use of this product is contraindicated in case of known or suspected allergies against components of this product." the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Additional Manufacturer Narrative
This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury(21 cfr sec.803.3) as the office staff reported the patient having an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products, one of which was a kulzer product, that required administration of benadryl by doctor.Symptoms resolved 2 hours after treatment.Allergy testing was stated to have been completed, but results have not been provided to the dental office at this time.Ifu states, "this product or one of its components may in particular cases cause hypersensitive reactions.The use of this product is contraindicated in case of known or suspected allergies against components of this product." the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Udi related data quality updates only no udi-pi/ batch number has been provided to kulzer by complainant despite several attempts.
Event or Problem Description
Patient was reported to have an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products.

• Brand Name: FLEXITIME LIGHT FLOW 1 X (2 X 50 ML)
• Common Device Name: 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: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 17963202
• Report Number: 3005665377-2023-00007
• Device Sequence Number: 6790216
• Product Code: ELW
• UDI-Device Identifier: J014400050400
• UDI-Public: +J014400050400
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 40005040
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 10/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female