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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD - PARKER SIZE 10 STAINLESS STEEL SURGICAL BLADE

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ASPEN SURGICAL PRODUCTS, INC. BARD - PARKER SIZE 10 STAINLESS STEEL SURGICAL BLADE Back to Search Results
Lot Number 0149935
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
Event Type  malfunction  
Event Description
While surgeon was performing a vaginal hysterectomy on a pt, a size 10 blade broke at the scalpel. All pieces were retrieved and placed in a sterile container. Retained in risk mgmt per organizational policy.
 
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Brand NameBARD - PARKER
Type of DeviceSIZE 10 STAINLESS STEEL SURGICAL BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
MDR Report Key7681204
MDR Text Key113908568
Report NumberMW5078330
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 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0149935
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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