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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP CONTROL

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ABBOTT GERMANY ARCHITECT SYPHILIS TP CONTROL Back to Search Results
Catalog Number 08D06-13
Device Problem Leak/Splash (1354)
Patient Problem Eye Injury (1845)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
 
Event Description
The customer reported that a male employee dropped a sample cup with architect (b)(6) control in it and some of the fluid splashed into his eye. The employee flushed his eye with water. The employee saw his physician but no additional treatment was given. The employee was not wearing any personnel protective eye wear. There was no reported impact to employee management.
 
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Brand NameARCHITECT SYPHILIS TP CONTROL
Type of DeviceSYPHILIS TP CONTROL
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key7990693
MDR Text Key126221471
Report Number3002809144-2018-00456
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K153730
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number08D06-13
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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