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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT DR; No Match
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ABBOTT GALLANT DR; No Match Back to Search Results
Model Number CDDRA500Q
Device Problem Failure to Interrogate (1332)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported, the device was unable to use bluetooth telemetry to be interrogated remotely.An in clinic follow up was performed and the device was interrogated using bluetooth telemetry successfully.The patient was stable and will continue being monitored.
 
Manufacturer Narrative
Further information was requested but not received.
 
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Brand Name
GALLANT DR
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19217923
MDR Text Key341456877
Report Number2017865-2024-40126
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public(01)05415067032003(10)P000137871(17)231231
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/30/2024
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 Date12/31/2023
Device Model NumberCDDRA500Q
Device Lot NumberP000137871
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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