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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL #15 SCALPEL SWANN MORTON

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DEROYAL #15 SCALPEL SWANN MORTON Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2017
Event Type  malfunction  
Event Description
A #15 scalpel blade fractured during surgical procedure. Required use of fluoroscopic to locate remaining piece in right foot 1st mpj area. Caused a 30 minute delay locating scalpel fragment. Piece was located and removed. Diagnosis or reason for use: bunionectomy.
 
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Brand Name#15 SCALPEL SWANN MORTON
Type of Device#15 SCALPEL
Manufacturer (Section D)
DEROYAL
MDR Report Key7078954
MDR Text Key93731210
Report NumberMW5073708
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
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