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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10) BLADE, SURGICAL

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10) BLADE, SURGICAL Back to Search Results
Catalog Number 0086
Device Problems Dull, Blunt (2407); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2020
Event Type  malfunction  
Event Description
Dull bard-parker blade (no. 10) in package. Would not cut through muscle. Fda safety report id# (b)(4).
 
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Brand NameBARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10)
Type of DeviceBLADE, SURGICAL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
caledonia MI 49316
MDR Report Key9763993
MDR Text Key181771070
Report NumberMW5093344
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 Risk Manager
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0086
Device Lot Number0200328
Was Device Available for Evaluation? Yes
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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