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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #20 STERILE BLADE

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SOUTHMEDIC INC. SOUTHMEDIC #20 STERILE BLADE Back to Search Results
Catalog Number 73-0420
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Tissue Damage (2104)
Event Date 09/13/2017
Event Type  Injury  
Event Description
A southmedic #20 blade ripped the pt's skin.
 
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Brand NameSOUTHMEDIC #20 STERILE BLADE
Type of Device#20 STERILE BLADE
Manufacturer (Section D)
SOUTHMEDIC INC.
barne OH
MDR Report Key6945563
MDR Text Key89239485
Report Number6945563
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Catalogue Number73-0420
Device Lot Number34165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/13/2017
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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