UNIVERSAL DISPOSABLE ACL KIT 8821

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-01 for UNIVERSAL DISPOSABLE ACL KIT 8821 manufactured by Conmed Corporation.

MAUDE Entry Details

Report Number1017294-2019-00131
MDR Report Key9142256
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-01
Date of Report2019-10-01
Date of Event2019-09-13
Date Mfgr Received2019-09-13
Device Manufacturer Date2019-07-24
Date Added to Maude2019-10-01
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 ContactMELANIE LANNON
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995209
Manufacturer G1CONMED CORPORATION
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal Code33773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNIVERSAL DISPOSABLE ACL KIT
Generic NameACL KIT
Product CodeKDD
Date Received2019-10-01
Catalog Number8821
Lot Number1034717
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer Address11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-01

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