GAMMEX NON LATEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for GAMMEX NON LATEX manufactured by Ansell Healthcare Products Llc.

Event Text Entries

[142338114] Operating room rn brought open package of sterile gloves that scrub tech was intending to put on to prep or table. Scrub tech immediately noted hair within glove packaging. Tech did not don gloves. Patient was not in room. Compromised gloves were removed from room. New gloves were opened and supplies and instruments were opened appropriately.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8526686
MDR Report Key8526686
Date Received2019-04-18
Date of Report2019-04-04
Date of Event2019-04-04
Report Date2019-04-04
Date Reported to FDA2019-04-04
Date Reported to Mfgr2019-04-18
Date Added to Maude2019-04-18
Event Key0
Report Source CodeUser Facility 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 NameGAMMEX NON LATEX
Generic NameSURGEON'S GLOVES
Product CodeKGO
Date Received2019-04-18
Lot Number1809062605
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerANSELL HEALTHCARE PRODUCTS LLC
Manufacturer Address1635 INDUSTRIAL RD. DOTHAN AL 36303 US 36303


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-18

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