MEDLINE INDUSTRIES, INC.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for MEDLINE INDUSTRIES, INC. manufactured by Medline Industries, Inc..

Event Text Entries

[85942303]
Patient Sequence No: 1, Text Type: N, H10


[85942304] Upon opening for a case the scrub tech found a dead fly on one of the laps in a c-section pack. Per site reporter: medline initiated a quality review investigation and supplied us with replacement product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6861422
MDR Report Key6861422
Date Received2017-09-13
Date of Report2017-08-14
Date of Event2017-05-04
Report Date2017-08-11
Date Reported to FDA2017-08-11
Date Reported to Mfgr2017-08-11
Date Added to Maude2017-09-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDLINE INDUSTRIES, INC.
Generic NameCESAREAN SECTION TRAY
Product CodeOHM
Date Received2017-09-13
Model NumberNA
Catalog NumberNA
Lot Number17AB7412
Device Availability*
Device Age1 DY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer Address1170 S NORTHPOINT BLVD WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-13

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