SENSICARE PIMICRO SURGICAL GLOVES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for SENSICARE PIMICRO SURGICAL GLOVES manufactured by Medline Industries, Inc..

Event Text Entries

[141318118] Placed a second pair of sterile gloves over a pair of purple gloves and immediately noticed a small hole in the second pair of sterile gloves. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085622
MDR Report Key8487582
Date Received2019-04-04
Date of Report2019-04-02
Date of Event2019-03-28
Date Added to Maude2019-04-05
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 Report0

Device Details

Brand NameSENSICARE PIMICRO SURGICAL GLOVES
Generic NameSURGEON'S GLOVES
Product CodeKGO
Date Received2019-04-04
Lot Number802981860870
OperatorHEALTH PROFESSIONAL
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 2019-04-04

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