CHROMIC GUT SUTURE N/A UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-05 for CHROMIC GUT SUTURE N/A UNKNOWN manufactured by Davis-gech.

Event Text Entries

[11764] During closure of an abdominal incision, suture needle snapped and tip broke off. Tip unable to be located visually. Abdominal x-ray done. Tip of needle located. Wound re-explored and tip of needle retrieved. Wound re-sutured.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number17465
MDR Report Key17465
Date Received1994-10-05
Date of Report1994-04-13
Date of Event1994-03-21
Date Facility Aware1994-03-29
Report Date1994-04-13
Date Reported to Mfgr1994-04-13
Date Added to Maude1994-11-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCHROMIC GUT SUTURE
Generic NameSUTURE NEEDLE
Product CodeHAS
Date Received1994-10-05
Model NumberN/A
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID Number3-0 SUTURE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key17393
ManufacturerDAVIS-GECH
Manufacturer AddressONE CYANAMID PLAZA WAYNE NJ 07470 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1994-10-05

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