REDI FLOW FILTER SYS CMPL 6/CS 631030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-02 for REDI FLOW FILTER SYS CMPL 6/CS 631030 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[143801225] (b)(4). Fda product code: gaz. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
Patient Sequence No: 1, Text Type: N, H10


[143801226] It was reported that the piece in the end of the instrument fell out into the patient. It was retrieved and a different product was used to complete the procedure. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2019-02010
MDR Report Key8572653
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-02
Date of Report2019-10-31
Date of Event2019-03-29
Date Mfgr Received2019-10-30
Date Added to Maude2019-05-02
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREDI FLOW FILTER SYS CMPL 6/CS
Generic NameTRAUMA, INSTRUMENT
Product CodeGAZ
Date Received2019-05-02
Catalog Number631030
Lot Number220806
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-05-02

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