EVACUATOR N/A 00-2500-004-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for EVACUATOR N/A 00-2500-004-10 manufactured by Zimmer Patient Care Division.

Event Text Entries

[1097] The synder hemovac was used on the patient after she had a carotid endarectomy procedure. Evacuator did not suck the wound properly and a large hematoma developeddevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number33141-1992-00002
MDR Report Key2189
Date Received1992-12-30
Date of Report1992-12-11
Date of Event1992-12-10
Report Date1992-12-11
Date Reported to FDA1992-12-11
Date Reported to Mfgr1992-12-11
Date Added to Maude1993-01-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEVACUATOR
Generic NameN/A
Product CodeEBR
Date Received1992-12-30
Model NumberN/A
Catalog Number00-2500-004-10
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key2015
ManufacturerZIMMER PATIENT CARE DIVISION


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.