UTERINE CORKSCREW 7655MB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-09 for UTERINE CORKSCREW 7655MB manufactured by Wisap.

Event Text Entries

[10661] The myoma drill, which previously was a two part stainless steel device, with the screw part fixed to the rod part, is now a single rod part, with the distal tip machined to a screw action. A separation, such as the reported event, will thus be prevented.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1001895
MDR Report Key13140
Date Received1994-05-09
Date of Report1994-04-28
Date of Event1994-02-07
Date Added to Maude1994-05-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUTERINE CORKSCREW
Generic NameUTERINE CORKSCREW
Product CodeHHO
Date Received1994-05-09
Catalog Number7655MB
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key13138
ManufacturerWISAP
Manufacturer AddressTOMBALL TX 77375 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-05-09

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