3M? IOBAN? ANTIMICROBIAL INCISE DRAPE N/A 6650EZ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-08 for 3M? IOBAN? ANTIMICROBIAL INCISE DRAPE N/A 6650EZ manufactured by 3m Health Care.

MAUDE Entry Details

Report Number2110898-2019-00093
MDR Report Key8873973
Report SourceCONSUMER
Date Received2019-08-08
Date of Report2019-11-06
Date of Event2019-07-02
Date Mfgr Received2019-07-09
Date Added to Maude2019-08-08
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 ContactDIANNE GIBBS
Manufacturer Street2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M COMPANY BROOKINGS
Manufacturer Street601 22ND AVE SOUTH
Manufacturer CityBROOKINGS SD 57006
Manufacturer CountryUS
Manufacturer Postal Code57006
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M? IOBAN? ANTIMICROBIAL INCISE DRAPE
Generic NameIOBAN INCISE DRAPE
Product CodeKKX
Date Received2019-08-08
Model NumberN/A
Catalog Number6650EZ
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-08-08

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