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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II INTRODUCER, CATHETER

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OSCOR INC. SAFESHEATH II INTRODUCER, CATHETER Back to Search Results
Model Number SS95
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2022
Event Type  malfunction  
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Brand NameSAFESHEATH II
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 Key15047447
Report Number1035166-2022-00084
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS95
Device Catalogue NumberSS95
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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