GEL-E DONUT - MEDIUM
Received Sep 24, 2014
Report 1218950-2014-07321 · MDR key 4309758
Device
Product problems
- Material Discolored
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED QTY (02) SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK SPOTS ON PRODUCT. THERE WAS NO REPORTED PT INCIDENT/INJURY.
Additional Manufacturer Narrative
(B)(4). QTY (02) SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK SPOTS ON PRODUCT. THERE WAS NO REPORTED PT INCIDENT/INJURY. THE 92025-C GEL-E-DONUT WAS EVALUATED. THE 92025-C GEL-E-DONUT WAS FOUND TO BE LEAKING ABOVE THE LETTER "U" ON THE BACK SIDE OF THE BLADDER. REPLACEMENT 92025-C-GEL-E DONUTS WERE ORDERED AND SHIPPED TO THE CUSTOMER SITE. THERE WAS A PRODUCT MALFUNCTION (UNRELATED TO MOLD). FOUND TO BE LEAKING ABOVE THE LETTER "U" ON THE BACK SIDE OF THE BLADDER. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.