FDA.reportPublic FDA data

MAUDE MDR 9468863

MDR report key
9468863
Report number
2027111-2019-00665
Event key
0
Event type
3
Date of event
2019-11-21
Date received
2019-12-13
Adverse event
0
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
1C8402, M ALEXIS O WND PROT/RET 5/BXPROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMERAPPLIED MEDICAL RESOURCESKWGC84021013562011365929R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-130

Event Narratives#

N

Patient 1

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

D

Patient 1

NAME OF PROCEDURE BEING PERFORMED: ANP. DETAILED DESCRIPTION OF EVENT: "WOULD LIKE TO NOTIFY YOU THAT AN ALEXIS WOUND RETRACTOR CAT# C8204. LOT#: 1365929 EXPIRATION: 08/18/2022 TORE DURING A PROCEDURE." THE ACCOUNT MANAGER SPOKE WITH AND RECEIVED AN EMAIL FROM THE CUSTOMER ON 22NOV2019. THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED. THE DATE OF THE EVENT WAS (B)(6) 2019. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. IT WAS UNKNOWN WHAT INSTRUMENTS WERE IN USE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHAT TYPE OF PROCEDURE WAS BEING PERFORMED. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT.