FDA.reportPublic FDA data

MAUDE MDR 7352183

MDR report key
7352183
Report number
MW5075963
Event key
0
Event type
3
Date received
2018-03-19
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0CADD EXT SET 60SET, ADMINISTRATION, INTRAVASCULARSMITHS MEDICAL ASD, INC.FPA57X474I N
1CADD EXT SET 60TUBINGSMITHS MEDICALBYX57X474I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-190

Event Narratives#

D

Patient 1

INBOUND PT REPORTS HER TUBING LEAKING TODAY, STATES THIS IS THE 3RD TUBING IN LAST 3 DAYS DOING THIS, THINKS THE LEAKING IS COMING OUT BY THE FILTER. LOT NUMBER OF TODAY'S LEAKING TUBING 57X474. NO FURTHER DETAILS PROVIDED. DIAGNOSIS OR REASON FOR USE: SPH.