FDA.reportPublic FDA data

MAUDE MDR 2163386

MDR report key
2163386
Report number
1018233-2011-00167
Event key
0
Event type
3
Date of event
2011-05-27
Date received
2011-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CHATERYL WASHINGTON
Address
8195 INDUSTRIAL BOULEVARD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD WOUND DRAINC.R. BARD, INC.GCYNAUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-0601. R

Event Narratives#

N

Patient 1

THE ACTUAL SAMPLE WAS DISCARDED BY THE USER FACILITY. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS FOR DAMAGED COMPONENTS PRIOR TO PRODUCT RELEASE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS. (B)(4).

D

Patient 1

IT WAS REPORTED VIA MEDWATCH THAT WHILE ATTEMPTING TO MANUALLY PULL THE DRAIN, THE END PIECE BECAME STUCK IN THE CLOSURE AND BROKE OFF IN THE PT. THE DRAIN WAS PLACED IN THE LUMBAR AREA ON (B)(6) 2011 FOR DRAINAGE AND REMOVED ON (B)(6) 2011. THE PT IS STABLE.