NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X1.102 STERILE 217005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X1.102 STERILE 217005 manufactured by Aspen Surgical Products, Caledonia.

MAUDE Entry Details

Report Number1836161-2019-00077
MDR Report Key9161760
Date Received2019-10-07
Date of Report2019-09-09
Date of Event2019-07-22
Date Mfgr Received2019-09-09
Date Added to Maude2019-10-07
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. JORDAN HACKERT
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
Manufacturer Phone6165367508
Manufacturer G1SAME AS ABOVE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X1.102 STERILE
Generic NameSURGICAL NEEDLE
Product CodeGAB
Date Received2019-10-07
Model Number217005
Lot Number154462
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-07

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