GEL-E DONUT - MEDIUM
Received Sep 24, 2014
Report 1218950-2014-07323 · MDR key 4309744
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK SPOTS ON PRODUCT. THERE WAS NO REPORTED PT INCIDENT/INJURY.
Additional Manufacturer Narrative
(B)(4). QTY SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK PORTS ON IT. THERE WAS NO REPORTED PT INCIDENT/INJURY. THE 92025-C GEL-E DONUT WAS EVALUATED. THE 92025-C GEL-E DONUT FUNCTIONED AS DESIGNED. REPLACEMENT 92025-C GEL-E DONUT WAS ORDERED AND SHIPPED TO THE CUSTOMER SITE. RETURNED 92025-C GEL-E DONUT WILL BE SCRAPED AFTER THE EVAL HAS BEEN COMPLETED. THERE WAS NOT A PRODUCT MALFUNCTION, FOUND TO BE PERFORMING AS DESIGNED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.