FDA.reportPublic FDA data

MAUDE MDR 7010586

MDR report key
7010586
Report number
2027111-2017-02104
Event key
0
Event type
3
Date of event
2017-10-05
Date received
2017-11-08
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
1C8301, S ALEXIS WND PROT/RET 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC83011013557011300056R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-080

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 - VIDEO ASSISTED THORACIC SURGERY - LOBECTOMY "REMOVING FROM PATIENT ALEXIS RIPPED IN HALF NO HARM TO PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL AT OCTOBER 10, 2017 FROM MATERIAL MANAGEMENT AT (B)(6) HOSPITAL. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE DEVICE IS WITH RISK MANAGEMENT DEPARTMENT AND WILL BE SECURED AT THE HOSPITAL. THE LOCATION OF THE RIP IS IN THE CENTER OF THE SHEATH. " THE RINGS ARE INTACT". ALL MATERIAL WAS RETRIEVED. PATIENT STATUS - "NO HARM TO PATIENT." TYPE OF INTERVENTION - NA.