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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD SINGLE USE SCALPEL BLAD

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SWANN MORTON, LTD SINGLE USE SCALPEL BLAD Back to Search Results
Model Number 0205
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 03/17/2017
Event Type  malfunction  
Event Description
Broke during procedure.
 
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Type of DeviceSINGLE USE SCALPEL BLAD
Manufacturer (Section D)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer (Section G)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key6802760
MDR Text Key83252961
Report Number9611194-2017-00002
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 Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0205
Device Lot Number4201506
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2017 Patient Sequence Number: 1
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