FDA.reportPublic FDA data

MAUDE MDR 2991026

MDR report key
2991026
Report number
1423537-2013-00012
Event key
0
Event type
3
Date of event
2013-01-30
Date received
2013-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

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
1DRAPE,TAPE,ADHESVIE,4INX18INDRAPE, ADHESIVE, AEROSOLCARDINAL HEALTHKGTA3524NO LOT GIVEN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-0601. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THERE WAS PEELING OF SKIN (10CMX 10CM) ABOVE THE KNEE WHEN THE DRAPE TAPE WAS REMOVED AFTER SURGERY ON A (B)(6) MALE WITH A HIP FRACTURE. THE PREP WAS DONE WITH CHLOREXIDINE 2% AND ALCOHOL 70%. A DRESSING WITH BACTIGRAS AND COMPRESSES WERE APPLIED. THE PATIENT WAS DOING WELL OVERALL.

N

Patient 1

NO LOT NUMBER WAS PROVIDED; WITHOUT THE LOT NUMBER WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD TO DETERMINE IF ANY DEVIATIONS TOOK PLACE DURING THE MANUFACTURE OF THIS DEVICE. NO SAMPLE WAS PROVIDED. WITHOUT THE ACTUAL SAMPLE, WE ARE UNABLE TO CONFIRM WHAT THE CUSTOMER EXPERIENCED, AND CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.