MAUDE MDR 451705

MDR report key
451705
Report number
1018233-2003-00007
Event key
0
Event type
3
Date received
2003-04-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS, MGR
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
1BARD FLAT SILICONE DRAINWOUND DRAINC.R. BARD, INC.GCYNA0070440UNKK782026NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-04-0101. R

Event Narratives#

D

Patient 1

WHEN ATTEMPTING TO REMOVE THE WOUND DRAIN, IT BROKE AND A PORTION OF THE DRAIN REMAINED INSIDE THE PT. NO PERFORATIONS WERE MADE IN THE DRAIN DURING PLACEMENT AND NO SUTURES WERE USED TO KEEP THE DRAIN IN PLACE. THE DRAIN WAS ANCHORED TO THE SKIN WITH 3-O NYLON. THE DRAIN WAS CHECKED DURING CLOSURE FOR FREE MOTION, NO BINDING WAS NOTED. NO X-RAYS, ETC. WERE MADE TO VERIFY PLACEMENT. FOR REMOVAL, THE SUTURE WAS CUT AND WHEN PULLING OUT THE DRAIN, IT BROKE 2 1/4" FROM THE FLAT PART OF DRAIN. A MINI-LAPAROTOMY WAS PERFORMED TO REMOVE THE DRAIN FRAGMENT.