COVIDIEN CURITY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for COVIDIEN CURITY manufactured by Cardinal Health, Inc..

Event Text Entries

[145113107] The 4x4 gauze sponges are disintegrating/fraying and sprinkling tiny bits of gauze into the surgical pocket. I have images depicting this. Covidien curity gauze sponges, lot: 18m083762, exp 2023-12-01.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8611595
MDR Report Key8611595
Date Received2019-05-15
Date of Report2019-01-29
Date of Event2019-01-22
Report Date2019-01-29
Date Reported to FDA2019-01-29
Date Reported to Mfgr2019-05-15
Date Added to Maude2019-05-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOVIDIEN CURITY
Generic NameFIBER, MEDICAL, ABSORBENT
Product CodeFRL
Date Received2019-05-15
Lot Number18M083762
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH, INC.
Manufacturer Address1 BUTTERFIELD TRAIL BLVD EL PASO TX 79906 US 79906


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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