SURGICAL PATTIE 1/2 X 1/2
Received Mar 24, 2014 · Event occurred Mar 10, 2014
Report 1226348-2014-11330 · MDR key 3696331
Device
Generic name
Surgical Sponge
Manufacturer
Codman & Shurtleff, Inc.Catalog number
80-1400
Lot number
415307
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.
Description of Event or Problem
THE AFFILIATE REPORTED: NO PROCEDURE. DURING SET UP, THE PACKAGE SAID 10 ITEMS BUT THEY COUNTED THEM AND IT WAS ONLY 9. PRODUCT WAS DISCARDED. NO PHOTOS AVAILABLE. NO PATIENT INVOLVED. NO FURTHER INFORMATION AVAILABLE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER.