Ferrosan Medical Devices A/s – FDA Warning Letter, Apr 30, 2015

On September 16, 2015, the FDA issued a Warning Letter to Ferrosan Medical Devices A/S following an inspection from April 27-30, 2015, at their Soeborg, Denmark facility. The inspection determined that their Surgiflo Hemostatic Matrix, an absorbable hemostatic, collagen-based device, was misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act.

The primary violation cited was the firm's failure to submit a Medical Device Report (MDR) within 30 calendar days for Complaint #200062395, which reasonably suggested the Surgiflo device caused or contributed to a patient's death. The firm became aware of this event on August 29, 2012, but no MDR was received by the FDA.

Furthermore, Ferrosan's revised MDR procedure (No. 10880, Issue Date: 28.04.2015) was deemed inadequate. Deficiencies included: 1. Failure to establish internal systems for timely and effective identification, communication, and evaluation of MDR events. Specifically, the procedure omitted the definition of "reasonably suggests" (803.20(c)(1)) and incorrectly stated that only one report should be submitted per event, regardless of the number of patients involved.