COSEAL 934072

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-18 for COSEAL 934072 manufactured by Baxter Healthcare - Hayward.

Event Text Entries

[60416116] (b)(6). As the sample was not returned a device analysis cannot be completed. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[60416117] It was reported that coseal had particulate matter. The event was further described as the polyethylene glycol (peg) solution would not flow out of the syringe due to what appeared to be visible particles in the peg syringes. It was further reported that the customer thought that the solution might not have fully mixed, possibly causing the particles. This occurred prior to patient use, so there was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2016-17483
MDR Report Key6115331
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-11-18
Date of Report2016-11-18
Date of Event2016-10-21
Date Mfgr Received2016-10-26
Device Manufacturer Date2015-10-21
Date Added to Maude2016-11-18
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - HAYWARD
Manufacturer Street2024 W WINTON AVE
Manufacturer CityHAYWARD CA 94545
Manufacturer CountryUS
Manufacturer Postal Code94545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOSEAL
Generic NameSEALANT,POLYMERIZING
Product CodeNBE
Date Received2016-11-18
Model NumberNA
Catalog Number934072
Lot NumberHA151037
ID NumberNA
Device Expiration Date2016-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - HAYWARD
Manufacturer AddressHAYWARD CA


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-18

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