DYNJ17488G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for DYNJ17488G manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1423395-2019-00020
MDR Report Key8680426
Date Received2019-06-07
Date of Report2019-06-18
Date of Event2018-12-01
Date Mfgr Received2019-06-03
Date Added to Maude2019-06-07
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 ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 600932753
Manufacturer CountryUS
Manufacturer Postal600932753
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameLAP SPONGE IN C-SECTION PACK
Product CodeOHM
Date Received2019-06-07
Catalog NumberDYNJ17488G
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.