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