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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 BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC BARD-PARKER RIB BACK CARBON STEEL SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Lot Number 0204656
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2020
Event Type  malfunction  
Event Description
Surgical blades failed to cut skin when being used.
 
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Brand NameBARD-PARKER RIB BACK CARBON STEEL SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key10173389
MDR Text Key195737500
Report Number10173389
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0204656
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2020
Event Location Hospital
Date Report to Manufacturer06/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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