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 Number: 33141-1992-00002
• MDR Report Key: 2189
• Date Received: 1992-12-30
• Date of Report: 1992-12-11
• Date of Event: 1992-12-10
• Report Date: 1992-12-11
• Date Reported to FDA: 1992-12-11
• Date Reported to Mfgr: 1992-12-11
• Date Added to Maude: 1993-01-25
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EVACUATOR
• Generic Name: N/A
• Product Code: EBR
• Date Received: 1992-12-30
• Model Number: N/A
• Catalog Number: 00-2500-004-10
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2015
• Manufacturer: ZIMMER PATIENT CARE DIVISION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-12-30