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U.S. Department of Health and Human Services

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

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OSCOR INC. SAFESHEATH® II INTRODUCER SET INTRODUCER, CATHETER Back to Search Results
Model Number SS7
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
It was reported that during implant, the sheath exhibited a break. Surgical equipment had to be used to complete the split. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
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Brand NameSAFESHEATH® II INTRODUCER SET
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 Key13422755
MDR Text Key284865502
Report Number1035166-2022-00022
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS7
Device Catalogue NumberSS7
Device Lot NumberDP14035
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2021
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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