STERILIZATION WRAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for STERILIZATION WRAP manufactured by Unknown.

Event Text Entries

[78469170]
Patient Sequence No: 1, Text Type: N, H10


[78469171] Retractor needed for case, but wrapper had hole in it. Needed to be flashed/reprocessed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6669521
MDR Report Key6669521
Date Received2017-06-27
Date of Report2017-06-19
Date of Event2017-04-20
Report Date2017-06-19
Date Reported to FDA2017-06-19
Date Reported to Mfgr2017-06-19
Date Added to Maude2017-06-27
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

Generic NameSTERILIZATION WRAP
Product CodeFRG
Date Received2017-06-27
OperatorNURSE
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-27

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