SNAP
Received Jun 14, 2021 · Event occurred May 19, 2021
Report 11991159 · MDR key 11991159
Device
Generic name
Negative Pressure Wound Therapy Non-powered Suction Apparatus
Manufacturer
Kci Usa, Inc.Catalog number
SKTF15X15
Lot number
8477883V002
Product problems
- Material Discolored
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
(B)(6): SNAP THERAPY SYSTEM DRESSING 15 X 15 CM WAS RECEIVED WITH DISCOLORED FOAM. FOAM IS BLUE, BY STANDARD, BUT APPEARED TO HAVE A GREEN EDGE. ALL PACKAGES WITHIN THE RECENT SHIPMENT CONTAINED FOAM THAT WAS DISCOLORED GREEN ALONG THE EDGE. ALL 10 BOXES OF PRODUCT WERE INSPECTED AND DISCOVERED TO HAVE SIMILAR DEFECT. PRODUCT WAS NOT APPLIED TO THE PATIENT. PRODUCT REP WAS CONTACTED ABOUT DEFECTIVE CONCERNS. PRODUCT IS BEING REPLACED AT NO CHARGE, WITH PRODUCT RETURNED TO DISTRIBUTOR/MANUFACTURER THROUGH PRODUCT REP.