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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX
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RADIOMETER MEDICAL APS ABL800 FLEX Back to Search Results
Model Number 393-800
Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  Injury  
Event Description
According to the complaint, the customer stated that the waste lines were popping off the connector.He got splashed/sprayed by waste line in the eyes/face and had to rinse the eyes.
 
Event Description
According to the complaint, the customer stated that the waste lines were popping off the connector.He got splashed/sprayed by waste line in the eyes/face and had to rinse the eyes.
 
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Brand Name
ABL800 FLEX
Type of Device
ABL800 FLEX
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, dnk 2700
DA  2700
MDR Report Key13655511
MDR Text Key288138468
Report Number1523456-2022-00001
Device Sequence Number1
Product Code CHL
UDI-Device Identifier05700693938011
UDI-Public(01)05700693938011(10)754R2504N009
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number393-800
Device Catalogue Number393-800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2022
Distributor Facility Aware Date02/22/2022
Event Location Hospital
Date Report to Manufacturer02/22/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient SexMale
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