FDA.reportPublic FDA data

MAUDE MDR 6505327

MDR report key
6505327
Report number
1060680-2017-00012
Event key
0
Event type
3
Date of event
2017-03-21
Date received
2017-04-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SARAH BENNETT
Address
200 DEBUSK LANE POWELL TN 37849 US
Phone
865-865-8653
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAFETY SCALPELHANDLE, SCALPELS & S SURGICALGDZSM45SCNS010633R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-190

Event Narratives#

N

Patient 1

AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT THE BLADE OF A SAFETY SCALPEL (PART NUMBER SM45SCNS) WAS NOT FULLY RETRACTED INTO THE HANDLE, THUS CREATING RISK FOR SERIOUS INJURY. A SAMPLE WAS NOT AVAILABLE FOR RETURN. HOWEVER, A PHOTO OF THE REPORTED FAILURE WAS PROVIDED FOR EVALUATION. THE SCALPEL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN ISSUED. AS OF THE DATE OF THIS REPORT, THE SCAR IS STILL OPEN. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED WHEN NEW AND CRITICAL INFORMATION IS RECEIVED.

D

Patient 1

THE SAFETY SCALPEL BLADE IS NOT FULLY RETRACTED WITHIN THE HANDLE. THIS NEARLY RESULTED IN AN INJURY TO A STAFF MEMBER. LOOSE BLADES ALSO WERE FOUND INSIDE ONE OF THE INNER BAGS. THIS WAS FOUND DURING UNPACKING OF THE PRODUCT.