HEMOVAC HYDROCOAT WOUND DRAIN N/A 2500-90-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for HEMOVAC HYDROCOAT WOUND DRAIN N/A 2500-90-10 manufactured by Snyder/zimmer.

Event Text Entries

[21080178] Hemovac pulled caught and snapped 3cm left in sq tissue, surgically removeddevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5094
• MDR Report Key: 5094
• Date Received: 1993-04-27
• Date of Report: 1993-04-07
• Date of Event: 1993-03-28
• Date Facility Aware: 1993-03-28
• Report Date: 1993-04-07
• Date Added to Maude: 1993-06-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• 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 HYDROCOAT WOUND DRAIN
• Generic Name: COMPACT EVACULATOR 400ML
• Product Code: FHF
• Date Received: 1993-04-27
• Model Number: N/A
• Catalog Number: 2500-90-10
• Lot Number: 9212-27298
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-MAR-93
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 4797
• Manufacturer: SNYDER/ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-27