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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LTD SINGLE USE SCALPEL BLADE

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SWANN-MORTON LTD SINGLE USE SCALPEL BLADE Back to Search Results
Model Number 0205
Device Problem Mechanical Problem (1384)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/04/2018
Event Type  malfunction  
Event Description
Description given by the healthcare facility: "the 15 blade broke off in a patient. This was from the extremity pack. " no further information was given. We have contacted the customer to provide more information if available.
 
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Brand NameSINGLE USE SCALPEL BLADE
Type of DeviceSINGLE USE SCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key7541917
MDR Text Key109628757
Report Number9611194-2018-00001
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,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0205
Device Catalogue Number0205
Device Lot Number4771710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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