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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD-PARKER ASPEN SURGICAL-A HILL ROM COMPANY BARD-PARKER SCALPEL BLADE

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BARD-PARKER ASPEN SURGICAL-A HILL ROM COMPANY BARD-PARKER SCALPEL BLADE Back to Search Results
Lot Number 0127941
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
Bard-parker # 11 blade broke during surgical incision. Half pf blade remained in handle, other half was removed from surgical incision.
 
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Brand NameBARD-PARKER SCALPEL BLADE
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
BARD-PARKER ASPEN SURGICAL-A HILL ROM COMPANY
caledonia MI 49316
MDR Report Key7137479
MDR Text Key95496717
Report NumberMW5074140
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0127941
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

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