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

Catalog Number 40005040

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Dyspnea (1816)

Event Date 08/22/2023

Event Type  Injury  

Event Description

Patient was reported to have an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products.

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.

• Brand Name: FLEXITIME LIGHT FLOW 1 X (2 X 50 ML)
• 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: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450-, ; GM 63450,
• MDR Report Key: 17963202
• MDR Text Key: 326005038
• Report Number: 3005665377-2023-00007
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 40005040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female