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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER BLADE, SCALPEL Back to Search Results
Lot Number 0204656
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/09/2021
Event Type  malfunction  
Event Description
During procedure, 10 blade broke on the field. All pieces recovered and removed from sterile field. Per hospital policy, radiology notified and x-ray taken. Doctor notified attending surgeon, x-ray negative for foreign body.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key11594738
MDR Text Key243148171
Report Number11594738
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 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0204656
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2021
Event Location Hospital
Date Report to Manufacturer03/31/2021
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 Unkown

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