FDA.reportPublic FDA data

MAUDE MDR 5461072

MDR report key
5461072
Report number
1018233-2016-00197
Event key
0
Event type
3
Date received
2016-02-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JANNA PARKS
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEG BAG WITH FLIP-FLO VALVELEG BAG STRAPSPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590FAQ151932NGZI4500R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-2501. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTION FOR USE STATES THE FOLLOWING: ? CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED.? THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT THE LEG STRAPS CAUSED A RASH, AS A RESULT THE PATIENT REQUIRED MEDICAL INTERVENTION. THE PATIENT WAS GIVEN HYDROCORTISONE CREAM FOR THE RASH. THE PATIENT ALSO ALLEGED THAT THE LEG STRAPS CAUSED A BRUISE ON HIS LEG.