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The purpose of this page is to provide a mechanism for hospitals and physicians to report complaints and adverse reactions to implanted LifeCell products. It is the goal of LifeCell Quality Assurance to assess every complaint and continually improve the safety and utility of these human tissue products.
Complaint Reporting Instructions: Open the link below, and complete the shaded fields in the Complaint Form. Then save the form to your computer directory. Print out the form and fax to LifeCell (908-947-1208) to the attention of the LifeCell Complaint Management Coordinator.
Click here to download complaint form.
Before use, physicians should review all risk information and essential prescribing information which can be found in the Strattice™ Reconstructive Tissue Matrix and AlloDerm® Regenerative Tissue Matrix Instructions for Use.
For complete safety information and complete instructions for the proper use of the SPY® Elite System, please refer to the SPY® Elite System Operator’s Manual and SPY® Elite System Kit Instructions for Use. The SPY® Elite System is intended for use as an adjunctive method of assessing tissue perfusion in plastic, reconstructive and micro-surgery. The SPY® Elite System is to be used under the direction of a physician. |
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