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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. ANGIODYNAMICS SAFESHEATH ULTRA LITE INTRODUCER, CATHETER

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OSCOR INC. ANGIODYNAMICS SAFESHEATH ULTRA LITE INTRODUCER, CATHETER Back to Search Results
Model Number VI7
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2022
Event Type  malfunction  
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Brand NameANGIODYNAMICS SAFESHEATH ULTRA LITE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683
Manufacturer Contact
daniel naut
3816 desoto blvd.
palm harbor, FL 34683
7279372511
MDR Report Key15103746
Report Number1035166-2022-00091
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVI7
Device Catalogue NumberVI7
Device Lot NumberDP-15017
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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