MAUDE MDR 742554

MDR report key
742554
Report number
1018233-2006-00100
Event key
0
Event type
3
Date of event
2006-03-02
Date received
2006-06-12
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
VIVIAN STEPHENS
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WOUND DRAINCR BARD, INC.GCYNA0090390UNKNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-06-120

Event Narratives#

N

Patient 1

NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR EVAL. A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE SPECIFIES THAT SURGICAL REMOVAL MAY BE NECESSARY IF THE DRAIN IS DIFFICULT TO REMOVE OR BREAKS. ADDITIONAL CAUTIONS INCLUDE: AVOID SUTURING THROUGH DRAINS; DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT PATH; PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH; DRAINS SHOULD BE CHECKED FOR FREE MOITION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE; DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND; DRAINS 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.