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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SURGICAL SCALPEL BLADE NO.15 BLADE, SCALPEL

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DEROYAL INDUSTRIES, INC. SURGICAL SCALPEL BLADE NO.15 BLADE, SCALPEL Back to Search Results
Model Number D6205
Device Problem Break (1069)
Patient Problem Tissue Damage (2104)
Event Date 01/07/2020
Event Type  Injury  
Event Description
The knife blade broke as the disc space was being incised by physician and assistant was holding the nerve root retractor to protect the spinal cord. As it broke, the broken fragment tore the dura. The nerve root and csf were visible. This was repaired with duragen and fibrin glue. Fda safety report id # (b)(4).
 
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Brand NameSURGICAL SCALPEL BLADE NO.15
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
MDR Report Key10740143
MDR Text Key213473396
Report NumberMW5097467
Device Sequence Number1
Product Code GES
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD6205
Device Lot Number3302002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/26/2020 Patient Sequence Number: 1
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