BIOMET BIOLOGICS MINI CTR BAL N/A 800-0505

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-11 for BIOMET BIOLOGICS MINI CTR BAL N/A 800-0505 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[138438789] (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10


[138438790] It was reported that during use of a platelet separator kit, the counterbalance was noted to be cracked but did not adversely affect the procedure. No adverse consequences has been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2019-01058
MDR Report Key8408171
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-11
Date of Report2019-04-17
Date of Event2019-02-12
Date Mfgr Received2019-04-16
Date Added to Maude2019-03-11
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
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameBIOMET BIOLOGICS MINI CTR BAL
Generic NameCENTRIFUGES
Product CodeJQC
Date Received2019-03-11
Model NumberN/A
Catalog Number800-0505
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
10 2019-03-11

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