FDA.reportPublic FDA data

MAUDE MDR 773300

MDR report key
773300
Report number
1649914-2006-00074
Event key
0
Event type
3
Date received
2006-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MEGAN SIMS
Address
ONE ALLENTOWN PARKWAY ALLEN TX 75002 US
Phone
972-972-9723
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LACRICATH LACRIMAL DUCT CATHETER, 2.0MMMANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL DILATORQUEST MEDICAL, INC.HNWLDC213*26859.K08NNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-08-140

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE CATHETERS WOULD NOT INFLATE. HE TRIED USING TWO DIFFERENT KITS (A TOTAL OF FOUR CATHETERS) AND NONE OF THEM WOULD WORK. NO PATIENT COMPLICATIONS WERE REPORTED. THE SURGEON REQUESTED, THAT THEY RETURN ALL UNITS FROM THEIR INVENTORY WITH THAT SAME LOT NUMBER. A TOTAL OF FOUR BOXES WILL BE RETURNED (TWO USED, AND TWO FROM INVENTORY). PRODUCT CODE DCP213-BI, LOT NUMBER 27137. THE PART NUMBER OF THE KIT IS DCP213-BI. THE PART NUMBER OF THE DEVICE THAT ALLEGEDLY FAILED IS LDC213.THE MDR WILL BE FILED ON THE LDC213 CODE LOT NUMBER 26859.K08.