VICRYL SUTURE 3-0 J-423

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-18 for VICRYL SUTURE 3-0 J-423 manufactured by Ethicon, Inc..

Event Text Entries

[7557] Needle for suture fractured but retrieved. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9563
MDR Report Key9563
Date Received1993-08-18
Date of Report1993-07-31
Date of Event1993-03-11
Report Date1993-07-31
Date Added to Maude1994-12-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVICRYL SUTURE 3-0
Product CodeHAS
Date Received1993-08-18
Catalog NumberJ-423
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key9215
ManufacturerETHICON, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1993-08-18

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