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U.S. Department of Health and Human Services

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

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SWANN-MORTON LTD SWANN-MORTON SCALPEL BLADE, SINGLE USE Back to Search Results
Model Number 0205
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
Unfortunately we cannot comment further at this moment in time as we are awaiting a sample to be returned to perform an investigation on. As well as this as we have not been provided any traceable information such as the lot number we cannot perform any traceability investigations for the device in question. We have asked the healthcare facility to clarify point made on their notification.
 
Event Description
Description given by healthcare facility: "blade broke off inside the patient". We have requested more information from the healthcare facility, e. G. , what procedure was being perfomed at the time of breakage.
 
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Brand NameSWANN-MORTON
Type of DeviceSCALPEL BLADE, SINGLE USE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key9109649
MDR Text Key219191587
Report Number9611194-2019-00005
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
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: 09/24/2019 Patient Sequence Number: 1
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