MAUDE Adverse Event Report: KULZER GMBH - HQ PALAPRESS VARIO, PINK, 1000G POWDER; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number	64707889
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient claimed to have experienced swelling and shortness of breath after her prosthesis was relined with palapress vario.The patient is reported to have been tested allergic to bpo.It was reported during the first contact that the patient is currently doing well.
Additional Manufacturer Narrative
The patient claims to have an allergy to benzoyl peroxide which is an ingredient in this material.Multiple attempts have been made to obtain further information and allergy testing regarding this incident and have been unsuccessful.No further information has been provided to date.It was reported during the first contact that the patient is currently doing well and they were searching for an alternative to our denture acrylic.The ifu states: "in case of known or suspected allergy to components of the product, its use is contraindicated.Do not use in case of known or suspected allergy against (meth)acrylate compounds or benzoyl peroxide.We will report this allegation out of an abundance of caution.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.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Additional Manufacturer Narrative
The patient claims to have an allergy to benzoyl peroxide which is an ingredient in this material.Multiple attempts have been made to obtain further information and allergy testing regarding this incident and have been unsuccessful.No further information has been provided to date.It was reported during the first contact that the patient is currently doing well and they were searching for an alternative to our denture acrylic.The ifu states: "in case of known or suspected allergy to components of the product, its use is contraindicated.Do not use in case of known or suspected allergy against (meth)acrylate compounds or benzoyl peroxide.We will report this allegation out of an abundance of caution.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.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
A patient claimed to have experienced swelling and shortness of breath after her prosthesis was relined with palapress vario.The patient is reported to have been tested allergic to bpo.It was reported during the first contact that the patient is currently doing well.

• Brand Name: PALAPRESS VARIO, PINK, 1000G POWDER
• Common Device Name: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 17928842
• Report Number: 3005665377-2023-00006
• Device Sequence Number: 6435822
• Product Code: EBI
• UDI-Device Identifier: J014647078890
• UDI-Public: +J014647078890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K902115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 64707889
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female