FDA.reportPublic FDA data

MAUDE MDR 7043527

MDR report key
7043527
Report number
2027111-2017-02115
Event key
0
Event type
3
Date of event
2017-09-28
Date received
2017-11-17
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
1C8405, XXL ALEXIS O WND PRO/RET 5/BXKGWAPPLIED MEDICAL RESOURCESKGWC8405101356501UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-1701. O

Event Narratives#

N

Patient 1

NO PRODUCT IS BEING RETURNED FOR EVALUATION, BUT A LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

D

Patient 1

PROCEDURE PERFORMED: WHIPPLE PROCEDURE EVENT DESCRIPTION: POSSIBLE BLISTERING OCCURRING AFTER A LARGE SIZE ALEXIS WAS USED IN A LONGER CASE. ON (B)(6) THE (B)(6) WAS INFORMED BY THE HOSPITAL THAT IN AROUND 5 WHIPPLE CASES WITH THE ALEXIS O XL AND XXL THE SURGICAL TEAM NOTICED THE PRESENCE OF "FLITTENE" (SMALL SKIN AREA WITH WATER BLISTER, AS IN THE CASE OF BURNS) IN THE AREA OF PRESSURE OF THE WHITE OUTER RING, DIRECTLY AFTER THE ALEXIS REMOVAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL TEAM MEMBER, 25TH OCTOBER: THIS WAS ONE OF THE CASES. THE ALEXIS WAS PLACED BY A RESIDENT. SKIN PREPARATION WAS DONE WITH AN IODINE SOLUTION, AND WIPED BEFORE THE ALEXIS/DRAPE WAS PLACED. BECAUSE OF THE BURNS IN PREVIOUS CASES THE SURGICAL TEAM PUT A WET DRAPE UNDER THE WHITE ALEXIS RING. UPON REMOVAL, BURNS WERE VISIBLE ON THE ENTIRE LEFT SIDE OF THE PATIENTS ABDOMEN. ALSO, SOME SKIN STUCK TO THE WET DRAPE AND CAME LOSE AND THERE WAS SOME NECROSIS OF THE SKIN. NO PICTURES WERE TAKEN. WHIPPLE CASES ARE USUALLY LONG, THIS CASE LASTED 5:25 HOURS. THE PATIENT WAS YOUNG FOR THIS TYPE OF CASE (

N

Patient 1

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT'S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCT. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT OR CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED, 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

ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL, ON FROM SENIOR REGULATORY AFFAIRS SPECIALIST, ON JANUARY 3, 2018. "THIS HOSPITAL MOST PROBABLY RECEIVED THOSE LOTS DIRECTLY FROM THE SALES REP BECAUSE THEY ARE DOING A SPECIFIC STUDY WITH THE (B)(6)IT MEANS THAT MODEL NUMBER REGARDING THESE CERS IS DEFINITELY C8404 (AS PER MDV REPORT) AND NOT AS INFORMED." ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL TM ON JANUARY 8, 2018: "BASED ON THE LOT TRACE, HOWEVER, LOT NUMBER INDEED DOESN'T MATCH WITH THESE INCIDENTS. THIS LOT WAS DELIVERED TO THE HOSPITAL ONLY IN OCTOBER (AFTER THE INCIDENTS), AND THERE`S NO TRACE THAT WAS DELIVERED EVEN TO THE REP. CUSTOMER MOST LIKELY GAVE US A WRONG LOT NUMBER, PROBABLY WHAT THEY STILL HAD ON THEIR SHELVES. CONSIDERED THE ABOVE EXPLANATION, LOT TRACE ATTACHED AND COMMUNICATION BACK AND FORTH BETWEEN US, THE REP AND CLINICAL TEAM IN AME, WE CONCLUDED THAT FOR THESE CERS THE LOT NUMBER IS UNKNOWN."