VALTRAC 8091-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-20 for VALTRAC 8091-00 manufactured by Davis/geck.

Event Text Entries

[11373] On 1/9/95 pt underwent surgery for a segmental resection. An anastomotic device was used. On 1/17/95 pt underwent surgery for dehiscence of anastomotic site. Device expelled after 10 days. Pt had sigmoid colostomy performed. At the time of second surgery, the distal portion of the anastomotic device was not totally attached, with leakage at the anastomosis site. Removal of implant with an end-to-end anastomosis. Incident report and medical device forms completed and forwarded to risk management. Administration notified. Devices removed from shelf pending further investigation. Company representative notified. Device labeled for single use. Patient medical status prior to event: fair 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. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: material degradation/deterioration. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 20929
• MDR Report Key: 20929
• Date Received: 1995-01-20
• Date of Report: 1995-01-18
• Date of Event: 1995-01-17
• Date Facility Aware: 1995-01-17
• Report Date: 1995-01-18
• Date Reported to FDA: 1995-01-18
• Date Reported to Mfgr: 1995-01-17
• 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: 1995-01-20
• Catalog Number: 8091-00
• Lot Number: 886270
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-93
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 20828
• Manufacturer: DAVIS/GECK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-01-20