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U.S. Department of Health and Human Services

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

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OSCOR INC. SAFESHEATH II INTRODUCER, CATHETER, PRODUCT CODE: DYB Back to Search Results
Model Number SS7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
 
Event Description
It was reported that during the implant procedure, the physician began access with the introducer and suspected a pneumothorax occurred. The patient was sent for a chest x-ray and a pneumothorax was confirmed. The patient was admitted and a chest tube was placed. No further patient complications have been reported as a result of this event.
 
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Brand NameSAFESHEATH II
Type of DeviceINTRODUCER, CATHETER, PRODUCT CODE: DYB
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor, fl
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor, fl
Manufacturer Contact
doug myers
3816 desoto
palm harbor, fl 
9372511
MDR Report Key10331519
MDR Text Key202009436
Report Number1035166-2020-00048
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSS7
Device Catalogue NumberSS7
Device Lot NumberDP11380
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
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