BARIATRIC PACK GOWN CMPJ08202B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for BARIATRIC PACK GOWN CMPJ08202B manufactured by Medline Industries, Inc..

Event Text Entries

[176060519] First grown scrub tech put on out of bariatric pack had two holes noted on forearm portion of gown. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092373
MDR Report Key9616107
Date Received2020-01-21
Date of Report2020-01-16
Date of Event2020-01-02
Date Added to Maude2020-01-22
Event Key0
Report Source CodeVoluntary 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 NameBARIATRIC PACK GOWN
Generic NameGOWN, SURGICAL
Product CodeFYA
Date Received2020-01-21
Catalog NumberCMPJ08202B
Lot Number19SBC101
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-21

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