HEMOVAC 2545-000-10 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-20 for HEMOVAC 2545-000-10 N/A manufactured by Zimmer Patient Care (oh).

Event Text Entries

[1297] Patient had an austin moore hip put in on 11/14/92. Patient was taken back to the floor and on 11/16/92 the drain was removed from the patient and the nurse noticed that there was no resistance and the tubing should have been longer. After x-rays were obtained, it was discovered that approximately 3" of tubing had remained in the patient. On 11/16/92 the patient went back into susrgery to have the piece of tubing removed. The patient is not experiencing any problems at this time. The product will be sent to mfg for a full evaluationdevice 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: 33458-1992-00001
• MDR Report Key: 1909
• Date Received: 1992-11-20
• Date of Report: 1992-11-19
• Date of Event: 1992-11-16
• Date Facility Aware: 1992-11-16
• Report Date: 1992-11-19
• Date Reported to FDA: 1992-11-19
• Date Reported to Mfgr: 1992-11-19
• Date Added to Maude: 1992-12-15
• 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: HEMOVAC
• Generic Name: WOUND EVACUATOR DRAIN
• Product Code: FHF
• Date Received: 1992-11-20
• Model Number: 2545-000-10
• Catalog Number: N/A
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 1781
• Manufacturer: ZIMMER PATIENT CARE (OH)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-20