COAXESS CATHETER SLU003 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-05-13 for COAXESS CATHETER SLU003 NA manufactured by Conceptus, Inc..

Event Text Entries

[51488] During a falloposcopy procedure, the coaxess catheter perforated the uterus with the straigtening mandrel in place. The perforation occurred close to the uterotubal ostium. No medical intervention was required. The adverse event is marked "other" because it is unknown as to whether or not the event results in permanent impairment of body function or permanent damage to body structure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951250-1997-00001
MDR Report Key91317
Report Source07
Date Received1997-05-13
Date of Report1997-05-11
Date of Event1997-04-14
Date Mfgr Received1997-04-14
Device Manufacturer Date1997-04-01
Date Added to Maude1997-05-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCOAXESS CATHETER
Generic NameUTERINE CATHETER
Product CodeMKO
Date Received1997-05-13
Model NumberSLU003
Catalog NumberNA
Lot NumberCO1756
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key90212
ManufacturerCONCEPTUS, INC.
Manufacturer Address1021 HOWARD AVE. SAN CARLOS CA 94070 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-05-13

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