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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER SAFETY BLADE

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER SAFETY BLADE Back to Search Results
Model Number 373910
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2017
Event Type  Injury  
Event Description
The bard -parker blade safety blade size 10 was attached to a reusable bard-parker blade holder for a surgical case. The metal blade fell off the grey plastic sheath during use. No injury.
 
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Brand NameBARD-PARKER SAFETY BLADE
Type of DeviceSAFETY BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
caledonia MI 49316
MDR Report Key6497068
MDR Text Key73066814
Report NumberMW5069103
Device Sequence Number1
Product Code GES
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number373910
Device Lot Number0118573
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 04/13/2017 Patient Sequence Number: 1
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