SENSICARE PI GREEN SYNTHETIC POLYISOPR SURG GLOVES 9120206560-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for SENSICARE PI GREEN SYNTHETIC POLYISOPR SURG GLOVES 9120206560-12 manufactured by Medline Industries, Inc..

Event Text Entries

[182526833] Overall poor quality - staff reports ripping and tearing. Issues seen throughout (b)(6) 2020. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093526
MDR Report Key9793031
Date Received2020-03-04
Date of Report2020-03-02
Date Added to Maude2020-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENSICARE PI GREEN SYNTHETIC POLYISOPR SURG GLOVES
Generic NameSURGEON'S GLOVES
Product CodeKGO
Date Received2020-03-04
Model Number9120206560-12
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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