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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER GMBH - HQ XANTOPREN COMFORT MEDIUM; MATERIAL, IMPRESSION
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KULZER GMBH - HQ XANTOPREN COMFORT MEDIUM; MATERIAL, IMPRESSION Back to Search Results
Catalog Number 5003415
Device Problems Off-Label Use (1494); Use of Device Problem (1670)
Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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) the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.An infants father notified kulzer that in (b)(6) 2022 his son had an impression taken with xantopren comfort medium for cleft palate surgery.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.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.
 
Event Description
An infants father notified kulzer that in (b)(6) 2022 his son had an impression taken with xantopren comfort medium for cleft palate surgery.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.
 
Event Description
An infants father notified kulzer that in (b)(6) 2022 his son had an impression taken with xantopren comfort medium for cleft palate surgery.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.An infants father notified kulzer that in (b)(6) 2022 his son had an impression taken with xantopren comfort medium for cleft palate surgery.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.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.
 
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Brand Name
XANTOPREN COMFORT MEDIUM
Type of Device
MATERIAL, IMPRESSION
Manufacturer (Section D)
KULZER GMBH - HQ
leipziger strasse 2
hanau, hesse 63450
GM  63450
MDR Report Key16482211
MDR Text Key310650302
Report Number1821514-2023-00001
Device Sequence Number1
Product Code ELW
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5003415
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2023
Event Location Hospital
Date Report to Manufacturer03/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age3 MO
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