FORTE EAR CLYLINDER ND04-011/02 C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-14 for FORTE EAR CLYLINDER ND04-011/02 C manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[117144587] The device is available for return. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[117144588] It was reported that there was a potential sterility breach on the packaging of the device. It was also reported that it was noticed prior to the procedure. It was further reported that there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2018-01580
MDR Report Key7782591
Report SourceDISTRIBUTOR
Date Received2018-08-14
Date of Report2018-10-19
Date of Event2018-07-17
Date Mfgr Received2018-10-11
Date Added to Maude2018-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. UNA BARRY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORTE EAR CLYLINDER
Generic NamePOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
Product CodeNHB
Date Received2018-08-14
Returned To Mfg2018-09-04
Catalog NumberND04-011/02 C
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.