VALTRAC 8083-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for VALTRAC 8083-00 manufactured by Davis/geck.

Event Text Entries

[14051] On 1/6/95 pt underwent surgery for a bowel resection. On 1/16/95 pt returned to surgery for exploratory laparotomy. The anastomosis ring had been completely passed at this time. The anastomosis site was totally disrupted. Pt was returned to or for sigmoid colostomy and drainage of abscess. Medical device report completed. Incident report sent to risk management. Incident report to company sales representative. Administration and bio-medical notified of incident. Devices removed from the shelf until incident is resolved. Device 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. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. 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: 20928
• MDR Report Key: 20928
• Date Received: 1995-01-18
• Date of Report: 1995-01-18
• Date of Event: 1995-01-16
• Date Facility Aware: 1995-01-16
• Report Date: 1995-01-18
• Date Reported to FDA: 1995-01-18
• Date Reported to Mfgr: 1995-01-16
• Date Added to Maude: 1995-03-22
• 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: VALTRAC
• Generic Name: ANASTOMOSIS RING
• Product Code: LNN
• Date Received: 1995-01-18
• Catalog Number: 8083-00
• Lot Number: 891738
• Device Expiration Date: 1996-07-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-JUN-94
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 20827
• Manufacturer: DAVIS/GECK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-01-18