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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VEDALAH SYPHILIS HEALTH CHECK
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VEDALAH SYPHILIS HEALTH CHECK Back to Search Results
Lot Number 07015
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
(b)(6) operates a mobile outreach program in a high risk community of (b)(6).Services provided include testing for the presence of treponemal antibodies in clients lacking a history of syphilis.During the period referenced above 57 tests were performed with the device in question (syphilis health check).Of these 12 specimens generated reactive results.These specimens were submitted to a reference lab for confirmation utilizing rpr and fta.The results were discordant.As a result, it was decided to utilize the device in question within two of eight ambulatory centers operated by (b)(6) on specimens testing.Reactive in an on-site rpr and verified for rpr and fta by a reference lab.In this case, however, the results utilizing health check elicited a non reactive result.This occurred in three of nine specimens tested.Dates of use: 07/04/2015 - 10/21/2015.
 
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Brand Name
SYPHILIS HEALTH CHECK
Type of Device
HEALTH CHECK
Manufacturer (Section D)
VEDALAH
cape may court house NJ
MDR Report Key5284925
MDR Text Key33163583
Report NumberMW5058414
Device Sequence Number1
Product Code LIP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2016
Device Lot Number07015
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/09/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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