AUTOSUTURE OMST10SB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-28 for AUTOSUTURE OMST10SB * manufactured by United States Surgical Corp..

Event Text Entries

[151540] The balloon did not inflate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1018786
MDR Report Key276054
Date Received2000-04-28
Date of Report2000-04-27
Date of Event2000-04-27
Date Added to Maude2000-05-04
Event Key0
Report Source CodeVoluntary 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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAUTOSUTURE
Generic NameINFLATION BULB
Product CodeFHO
Date Received2000-04-28
Model NumberOMST10SB
Catalog Number*
Lot Number203219
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key267192
ManufacturerUNITED STATES SURGICAL CORP.
Manufacturer Address150 GLOVER AVE. NORWALK CT 06856 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-04-28

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