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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. #11 BARD-PARKER CARBON STEEL SURGICAL BLADE BLADE, SCALPEL

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ASPEN SURGICAL PRODUCTS, INC. #11 BARD-PARKER CARBON STEEL SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Lot Number 0050683
Device Problem Break (1069)
Patient Problems Inflammation (1932); Tissue Damage (2104)
Event Date 12/15/2017
Event Type  Injury  
Event Description
Pt admitted with right shoulder superior labral tear and right shoulder rotator cuff tendonitis / subacromial impingement. During surgery, the #11 surgical blade broke. The loose scalpel piece was able to be removed in its entirety from the subacromial region in an arthroscopic procedure.
 
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Brand Name#11 BARD-PARKER CARBON STEEL SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
6945 southbelt drive se
caledonia MI 49316
MDR Report Key7179036
MDR Text Key96965153
Report NumberMW5074502
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 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0050683
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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