MAUDE MDR 2578321

MDR report key
2578321
Report number
1044475-2012-00045
Event key
0
Event type
3
Date of event
2012-04-24
Date received
2012-05-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ELAINE BURKLE, RN
Address
P.O. BOX 12600 RTP NC 27709 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PILLING GOULIAN SKIN GRAFT KNIFE SETSKIN GRAFT KNIFE SETTELEFLEXEMF050200UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-140

Event Narratives#

D

Patient 1

THE EVENT IS REPORTED AS: THE BLADE CUT THE PT'S SKIN. THE CUT WAS SUPERFICIAL AND DID NOT REQUIRE ANY STITCHES.

N

Patient 1

NO DEVICE SAMPLE IS AVAILABLE FOR INVESTIGATION. NO LOT # AVAILABLE. CLAIM CANNOT BE CONFIRMED.