BERKLEY VACUUM CURETTAGE SYSTEM VC2-115VAC60HZ NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-23 for BERKLEY VACUUM CURETTAGE SYSTEM VC2-115VAC60HZ NA manufactured by Cabot Medical Corp..

Event Text Entries

[161821] Dilation and evacuation machine was noted to have less suction than usual during a procedure. The pt underwent an ultrasound which showed a small amount of tissue remaining. The machine was checked, and it was discovered that the plastic filter housing was cracked resulting in less suction. This was replaced and vacuum was verified to 68 cm of mercury. The pt returned the following day for a repeat procedure. A small amount of tissue was suctioned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number251744
MDR Report Key251744
Date Received1999-11-23
Date of Report1999-10-07
Date of Event1999-09-21
Date Facility Aware1999-09-21
Report Date1999-10-07
Date Reported to Mfgr1999-10-07
Date Added to Maude1999-12-01
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 NameBERKLEY VACUUM CURETTAGE SYSTEM
Generic NameDILATION AND EVACUATION MACHINE
Product CodeHGG
Date Received1999-11-23
Model NumberVC2-115VAC60HZ
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age8 YR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key243821
ManufacturerCABOT MEDICAL CORP.
Manufacturer Address2021 CABOT BLVD WEST. LANGHORNE PA 19047 US
Baseline Brand NameBERKLEY VACUUM CURETTAGE SYSTEM
Baseline Generic NameDILATION AND EVACUATION MACHINE
Baseline Model NoVC2-115VAC60HZ
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1999-11-23

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