2.0 VICRYL (POLYGLACTIN 910) SUTURE NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for 2.0 VICRYL (POLYGLACTIN 910) SUTURE NEEDLE manufactured by Ethicon, Inc..

Event Text Entries

[5184] During laparascopic examination with uterine suspension, needle broke and retained in patient. Needle removed in surgery. No further problems encountered. 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 Number9163
MDR Report Key9163
Date Received1994-07-29
Date of Report1994-07-14
Report Date1994-07-14
Date Added to Maude1994-12-01
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 Name2.0 VICRYL (POLYGLACTIN 910) SUTURE NEEDLE
Product CodeHAS
Date Received1994-07-29
Lot NumberBE4110
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key8823
ManufacturerETHICON, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1994-07-29

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