FDA.reportPublic FDA data

MAUDE MDR 7379897

MDR report key
7379897
Report number
2027111-2018-00124
Event key
0
Event type
3
Date of event
2018-02-01
Date received
2018-03-28
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
1C8301, S ALEXIS WND PROT/RET 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC83011013557011310445Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-280

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A TORN SHEATH. ENGINEERING OBSERVED CUT MARKS ON THE SHEATH NEAR THE OUTER RING, A LARGE TEAR, AND SEPARATION OF THE FILM FROM THE INNER RING. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE TEAR IN THE SHEATH WAS CAUSED BY THE INSTRUMENTATION USED BY THE SURGEON. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE UPDATES TO PRODUCT LITERATURE AND/OR DEVICE ENHANCEMENTS, WHICH ARE INTENDED TO FURTHER MINIMIZE THE LIKELIHOOD FOR THIS TYPE OF EVENT TO OCCUR.

D

Patient 1

PROCEDURE PERFORMED: "HERNIOTOMY". EVENT DESCRIPTION: "INSERT THE GREEN RING THROUGH THE INCISION. WHEN SURGEON CURLING THE WHITE RING BUT THE WOUND SHEATH WAS BROKEN ON THE GREEN RING. PLEASE CONSULT WITH PHOTOS." TYPE OF INTERVENTION: NA. PATIENT STATUS: "NO PATIENT INJURY".