UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-16 for UNK * manufactured by Unk.

Event Text Entries

[51849] During laparoscopic bilateral tubal fulguration, the tenaculum tore through the cervix. The cervix required repair by suturing. Surgical short procedure pt; discharged same day.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number91956
MDR Report Key91956
Date Received1997-05-16
Date of Report1997-05-14
Date of Event1997-05-08
Date Facility Aware1997-05-12
Report Date1997-05-14
Date Reported to FDA1997-05-14
Date Added to Maude1997-05-21
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 NameUNK
Generic NameTENACULUM
Product CodeHDC
Date Received1997-05-16
Model NumberUNK
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key90833
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-05-16

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