PROLENE 2.0 SURGICAL SUTURE NEEDLE CT-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for PROLENE 2.0 SURGICAL SUTURE NEEDLE CT-2 manufactured by Ethicon, Inc..

Event Text Entries

[3588] While performing left inguinal hernia repair with suture needle in question, it was noted that tip of needle was missing. It could not be located in the surgical wound or surrounding sterile field. X-rays taken immediately post-op were negative. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6796
MDR Report Key6796
Date Received1993-07-22
Date of Report1993-02-05
Date of Event1993-02-01
Date Facility Aware1993-02-01
Report Date1993-02-05
Date Reported to Mfgr1993-02-05
Date Added to Maude1993-10-15
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 NamePROLENE 2.0 SURGICAL SUTURE NEEDLE
Product CodeHAS
Date Received1993-07-22
Model NumberCT-2
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key6479
ManufacturerETHICON, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-07-22

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