OR STERILE TOWEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for OR STERILE TOWEL manufactured by Allcare, Inc..

Event Text Entries

[139421923] There was excessive lint coming off of the sterile towels. The surgical site had to be washed off and re-prepped. This has been investigated by our infection prevention team.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8439290
MDR Report Key8439290
Date Received2019-03-21
Date of Report2019-03-13
Date of Event2019-03-01
Report Date2019-03-13
Date Reported to FDA2019-03-13
Date Reported to Mfgr2019-03-21
Date Added to Maude2019-03-21
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 OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOR STERILE TOWEL
Generic NameACCESSORY, SURGICAL APPAREL
Product CodeLYU
Date Received2019-03-21
Lot Number11RI14
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALLCARE, INC.
Manufacturer Address2580 FOXFIELD RD STE 101 ST CHARLES IL 60174 US 60174


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-21

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