FDA.reportPublic FDA data

MAUDE MDR 8533458

MDR report key
8533458
Report number
2020394-2019-00502
Event key
0
Event type
3
Date received
2019-04-19
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
JUDITH LUDWIG
Address
1625 W 3RD ST. TEMPE AZ 85281 US
Phone
480-480-4803
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD PTFE FELTPTFE FELTBARD ACCESS SYSTEMSDXZ007959007959UNKNOWN* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-190

Event Narratives#

N

Patient 1

AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. THE DEVICE IS LABELED FOR SINGLE USE.

D

Patient 1

THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 7959 BARD PTFE FELT EXPERIENCED A MATERIAL SPLIT, CUT OR TORN. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WITH WEIGHT NOT PROVIDED. THE 7959 BARD PTFE FELT WAS NOT RETURNED TO THE MANUFACTURER LIMITING INVESTIGATION.