CONVERTORS 39049

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for CONVERTORS 39049 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[185050835] The physician's gown was noted to be misaligned at the seams creating holes in the sterile gown. Operation room team members covered it with a tegaderm and kept working. The integrity of paper gowns is being called into question with multiple issues and recalls.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9882725
MDR Report Key9882725
Date Received2020-03-26
Date of Report2020-03-03
Date of Event2020-02-12
Report Date2020-03-03
Date Reported to FDA2020-03-03
Date Reported to Mfgr2020-03-26
Date Added to Maude2020-03-26
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 NameCONVERTORS
Generic NameGOWN, SURGICAL
Product CodeFYA
Date Received2020-03-26
Model Number39049
Catalog Number39049
Lot Number19KBD502
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address785 FORT MILL HWY. FORT MILL SC 29707 US 29707


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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