FDA.reportPublic FDA data

MAUDE MDR 2439343

MDR report key
2439343
Report number
1423537-2012-00004
Event key
0
Event type
3
Date of event
2012-01-07
Date received
2012-02-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHELE DONATICH
Address
1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US
Phone
847-847-8478
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESTEEM STRETCHY SYNTH EXAM GLOVEVINYL PATIENT EXAMINATION GLOVECARDINAL HEALTHLYZ8882B6Y11N023R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-02-0601. O

Event Narratives#

D

Patient 1

A REHABILITATION NURSING TECHNICIAN BEGAN TO OPEN A BOX OF GLOVES BY PULLING OPEN THE PERFORATED TAB ON THE TOP OF THE BOX AND WAS "SCRATCHED" BY AN OBJECT INSIDE THE BOX. WHEN THE BOX WAS FULLY OPENED A "WRAPPED BLADE" WAS INSIDE THE BOX AT THE VERY TOP UNDER THE PERFORATED TAB. IT APPEARED TO BE SIMILAR TO A BOX CUTTER BLADE, WRAPPED IN HEAVY PAPER AND THEN WRAPPED AGAIN WITH HEAVY TAPE. THE EMPLOYEE'S SKIN WAS BROKEN SLIGHTLY BUT DID NOT BLEED. SHE RECEIVED MEDICAL ATTENTION AND TESTING THAT HER EMPLOYER DOES WHEN THERE IS EXPOSURE TO BODY FLUIDS, INCLUDING A TETANUS INJECTION.

N

Patient 1

(B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING WAS DONE. AN INVESTIGATION WAS INITIATED PER THE RECEIVED PHOTO. THE WRAPPED BLADE IS USED BY THE EMPLOYEE TO CUT OFF THE SEALING TAPE TO THE SHIPPING CASE. ONE OF THE EMPLOYEES ACCIDENTALLY DROPPED THE BLADE INTO THE BOX WHILE PACKING. THE MANUFACTURER/SUPPLIER, (B)(4), WAS APPRISED OF THIS COMPLAINT FOR CLOSE MONITORING DURING THE PACKING PROCESS. ACTIONS TO BE TAKEN ARE: (B)(4).