VERASEAL GLUE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for VERASEAL GLUE manufactured by Medtronic Ireland.

Event Text Entries

[181629342] I had a vein procedure done on (b)(6) 2019. The opening would never heal. I had discharge and granules oozing from my leg. Eventually my vein developed sore every inch or so up my leg. I&d culture showed pseudomonas. Hospitalized twice for iv antibiotics and debridement surgery. Eventually i had to have a picc line inserted and administered abx 3 times a day. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093315
MDR Report Key9763586
Date Received2020-02-26
Date of Report2020-02-24
Date of Event2019-11-05
Date Added to Maude2020-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERASEAL GLUE
Generic NameAGENT, OCCLUDING, VASCULAR, PERMANENT
Product CodePJQ
Date Received2020-02-26
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2020-02-26

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