MALYUGIN RING MAL-1001-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for MALYUGIN RING MAL-1001-1 manufactured by Microsurgical Technology, Inc..

Event Text Entries

[126526797] When surgeon engaged the ring it was found to be bent. The manufacturer provided a returns good authorization number for product return evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8050494
MDR Report Key8050494
Date Received2018-11-08
Date of Report2018-11-01
Date of Event2018-10-23
Report Date2018-11-01
Date Reported to FDA2018-11-01
Date Reported to Mfgr2018-11-08
Date Added to Maude2018-11-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 NameMALYUGIN RING
Generic NameCLIP, IRIS, RETRACTOR
Product CodeHOC
Date Received2018-11-08
Returned To Mfg2018-11-01
Catalog NumberMAL-1001-1
Lot Number103124
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICROSURGICAL TECHNOLOGY, INC.
Manufacturer Address8415 154TH AVENUE NE REDMOND WA 98052 US 98052


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-08

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