Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL PRODUCTS LABORATORIES, INC. DURAFLOR HALO 5% VARNISH; VARNISJ
  • 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
 

MEDICAL PRODUCTS LABORATORIES, INC. DURAFLOR HALO 5% VARNISH; VARNISJ Back to Search Results
Model Number 1030-WB32
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Abdominal Pain (1685); Fever (1858); Pain (1994); Abdominal Cramps (2543); Confusion/ Disorientation (2553)
Date of Event 05/16/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product not returned for evaluation.
 
Event or Problem Description
The patient had a duraflor halo treatment.Later that day the child experienced fever, pain at stomach, pain at arms, and hallucination.Parent administered tylenol.This was the first time that the patient in question used this product.The patient is allergic to pineapple, dairy, and she is coeliac.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DURAFLOR HALO 5% VARNISH
Common Device Name
VARNISJ
Manufacturer (Section D)
MEDICAL PRODUCTS LABORATORIES, INC.
9990 global road
philadelphis PA 19115
MDR Report Key6604490
Report Number1941138-2017-00003
Device Sequence Number1010454
Product Code LBH
UDI-Device Identifier00686864026662
UDI-Public00686864026662
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K040098
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/30/2017
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 Dentist
Device Model Number1030-WB32
Device Catalogue Number1030-WB32
Device Lot Number53156
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2017
Initial Report FDA Received Date06/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age5 YR
-
-