FDA.reportPublic FDA data

MAUDE MDR 6664655

MDR report key
6664655
Report number
2027111-2017-01865
Event key
0
Event type
3
Date of event
2017-05-09
Date received
2017-06-23
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
WENDY KOBAYASHI
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
1C8312, XS ALEXIS WND PROT/RET 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC83121013556011292166Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-230

Event Narratives#

N

Patient 1

THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

PROCEDURE PERFORMED: CS - "THE SURGEON INSERTS THE GREEN RING TO PATIENT BODY, AND THEN THEY STARTING TO CURL THE WHITE RING WITH WOUND SHEATH. SUDDENLY, THE WOUND SHEATH JUST CAME APART NEAR GREEN RING." TYPE OF INTERVENTION: NO INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. PATIENT STATUS: "FINE".