• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. DENTAPURE DP365 CARTRIDGE DENTAL UNIT WATERLINE PURIFICATION CARTRIDGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CROSSTEX INTERNATIONAL INC. DENTAPURE DP365 CARTRIDGE DENTAL UNIT WATERLINE PURIFICATION CARTRIDGE Back to Search Results
Model Number DP365B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Reaction (2414)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
Crosstex received a report from a dental office reporting a patient suffered anaphylactic shock symptoms. The dentist indicated this is the first time the patient had been exposed to dentapure-treated water and is concerned the iodine may have been the cause of the reaction. The dentist reported treating the patient with benadryl and monitored the patient through recovery in the dental office. The patient is reported to be fine. The patient was reported to be allergic to latex and rubber. Limited information on the extent of the anaphylactic symptoms was provided. The patient was able to swallow benadryl orally. No lot number of the dentapure cartridge was provided. Multiple attempts to gather more information from the dental office were made. Crosstex cannot confirm dentapure was the cause of the patient reaction. Iodine is not an allergen and thus cannot cause an allergic reaction (j emerg med. 2010 nov;39(5):701-7. Doi: 10. 1016/j. Jemermed. 2009. 10. 014. Epub 2010 jan 4. ). It is suspected the reported reaction was caused by something other than the iodine in the dentapure cartridge. Crosstex has not received any similar complaints for dentapure. This complaint will continue to be monitored in the crosstex complaint handling system.
 
Event Description
Crosstex received a report from a dental office reporting a patient suffered anaphylactic shock symptoms. The dentist indicated this is the first time the patient had been exposed to dentapure-treated water and is concerned the iodine may have been the cause of the reaction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDENTAPURE DP365 CARTRIDGE
Type of DeviceDENTAL UNIT WATERLINE PURIFICATION CARTRIDGE
Manufacturer (Section D)
CROSSTEX INTERNATIONAL INC.
10 ranick road
hauppauge NY 11788
Manufacturer (Section G)
CROSSTEX INTERNATIONAL INC.
10 ranick road
hauppauge NY 11788
Manufacturer Contact
sadie martin
10 ranick road
hauppauge, NY 11788
7632487189
MDR Report Key7772929
MDR Text Key116774005
Report Number2433773-2018-00002
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDP365B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/10/2018 Patient Sequence Number: 1
-
-