FDA.reportPublic FDA data

MAUDE MDR 2030678

MDR report key
2030678
Report number
1018233-2011-00046
Event key
0
Event type
3
Date of event
2011-02-11
Date received
2011-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NYCOLE SAYER
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
1CLOSED WOUND SUCTION KITC.R. BARD, INC.GCYNA0043610UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-1801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PT WHO HAD RIGHT KNEE ARTHROPLASTY SURGERY HAD A DRAIN PLACED. UPON MANUAL REMOVAL, THE DRAIN BROKE. PT WAS RETURNED TO SURGERY FOR REMOVAL OF BROKEN DRAIN PORTION VIA ARTHROTOMY. THE DRAIN WAS INDWELLING FOR TWO DAYS.

N

Patient 1

THE SAMPLE WAS RETAINED AT THE USER FACILITY. THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN." AN ADDITIONAL WARNING STATES: "DRAIN BREAKAGE MAY REQUIRE SURGICAL REMOVAL." (B)(4).