LAP SPONGES MDS251518LF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for LAP SPONGES MDS251518LF manufactured by Medline Industries Inc..

Event Text Entries

[181781025] Hair found in sterile lap sponge package. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093371
MDR Report Key9769912
Date Received2020-02-27
Date of Report2020-02-25
Date of Event2020-02-25
Date Added to Maude2020-02-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAP SPONGES
Generic NameGAUZEL SPONGE, INTERNAL
Product CodeEFQ
Date Received2020-02-27
Catalog NumberMDS251518LF
Lot Number84319080085
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressNORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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