MAUDE MDR 6898772

MDR report key
6898772
Report number
2320762-2017-00011
Event key
0
Event type
3
Date of event
2017-08-28
Date received
2017-09-27
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
MS. SARAH BENNETT
Address
200 DEBUSK LANE POWELL TN 37849 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1#11 SAFETY SCALPELHANDLE, SCALPELS & S SURGICALGDZD4511A44421536R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-270

Event Narratives#

N

Patient 1

INVESTIGATION IS STILL ONGOING. WILL PROVIDE FOLLOW UP WHEN MORE INFORMATION IS RECEIVED.

D

Patient 1

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