FDA.reportPublic FDA data

MAUDE MDR 7701083

MDR report key
7701083
Report number
2027111-2018-00232
Event key
0
Event type
3
Date received
2018-07-18
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#

Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1C8322, XS ALEXIS WND PROT/RET SHRT 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC83221014325011308093R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-180

Event Narratives#

N

Patient 1

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

D

Patient 1

PROCEDURE PERFORMED: UNK. "THE SHEAT ATTACHMENT PEELED OFF FROM THE RING APPROXIMATE SIZE 1-2 CM." "OUR CUSTOMER MISTAKENLY THROWN THE ACTUAL USED PRODUCT, SO WE CAN`T RETURN FOR INSPECTION." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 21JUN2018 FROM, (B)(4), DISTRIBUTOR. "THE INCIDENT OCCUR AFTER PLACEMENT OF THE PRODUCT, WHILE THE DOCTOR TRIED TO ROLL UP THE SHEATH." TYPE OF INTERVENTION: UNK. PATIENT STATUS: UNK.