MAUDE Adverse Event Report: KULZER GMBH - HQ XANTOPREN COMFORT MEDIUM; MATERIAL, IMPRESSION

Catalog Number 50034105

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Event Description

An infant's father notified kulzer that in (b)(6) 2022 his son had an impression taken with xantopren comfort medium for cleft palate treatment.Some of the material was swallowed and ingested.The infant extruded (bowel movement) some of the material 4 days after and then again in (b)(6) 2023, according to the father.

Manufacturer Narrative

This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.The ifu contains the following warning and precaution: "do not swallow or ingest.If health problems arise after swallowing impression material, seek medical attention immediately.Intestinal blockage may arise in rare cases." as the baby was 3 months old when the impression was performed, the dentist did not follow the additional warning and precaution: "do not use in children under 6 years of age." this product is not sold in the usa or canada, however, a comparable product is.We will report this incident out of an abundance of caution.

• Brand Name: XANTOPREN COMFORT MEDIUM
• 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: 16500637
• MDR Text Key: 310853959
• Report Number: 3005665377-2023-00001
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K991425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 50034105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2023
• 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
• Patient Age: 3 MO
• Patient Sex: Male