CENTURION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for CENTURION manufactured by Centurion Medical Products.

Event Text Entries

[129900473] Plastic connector site of catheter was cracked.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038445-2018-00001
MDR Report Key8128757
Date Received2018-12-04
Date of Report2018-12-03
Date of Event2018-10-30
Date Mfgr Received2018-11-19
Date Added to Maude2018-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. KAREN KOWALCZYK
Manufacturer Street100 CENTURION WAY
Manufacturer CityWILLIAMSTON MI 48895
Manufacturer CountryUS
Manufacturer Postal48895
Manufacturer Phone5175451122
Manufacturer G1CENTURION MEDICAL PRODUCTS
Manufacturer Street3310 MAIN STREET
Manufacturer CitySALISBURY NC 28147
Manufacturer CountryUS
Manufacturer Postal Code28147
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCENTURION
Generic NameCARDIAC CATHETERIZATION KIT
Product CodeOES
Date Received2018-12-04
Lot Number2017092950
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCENTURION MEDICAL PRODUCTS
Manufacturer Address100 CENTURION WAY WILLIAMSTON MI 48895 US 48895


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-04

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