2G OTOMIMIX N/A 7014-3266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-28 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.

Event Text Entries

[142538716] Zimmer biomet complaint (b)(4). Lot number - possible lot numbers are: 016570, 582090, 402320. Expiration date - lot 016570: june 2, 2020; lot 582090: may 2, 2020; lot 402320: november 1, 2019. Health professional - initial reporter has an email associated with a hospital. Occupation - initial reporter has an email associated with a hospital, no other information. Initial reporter also sent report to fda - the user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6). Device manufacture date - lot 016570: june 2, 2018; lot 582090: may 2, 2018; lot 402320: november 1, 2017. Additional narratives/data - customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[142538737] It was reported that the customer has had various problems with the mix. Either the mix has been too loose or too dry but still not hardened after 10 min. Up to two times the customer has used up to 3-4 products to get it right while the patient has been in narcosis. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2019-00189
MDR Report Key8460613
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-03-28
Date of Report2019-07-30
Date Mfgr Received2019-07-29
Date Added to Maude2019-03-28
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 ContactMR. ALAN MUNOZ
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9043677142
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name2G OTOMIMIX
Generic NameCEMENT, STOMAL APPLIANCE, OSTOMY
Product CodeNEA
Date Received2019-03-28
Model NumberN/A
Catalog Number7014-3266
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-28

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