DEROYAL
Received Feb 5, 2014 · Event occurred Jan 3, 2014
Report 2320762-2014-00004 · MDR key 3625116
Device
Product problems
- Product Quality Problem
Patient
Not reported
- Blood Loss
Narrative
Additional Manufacturer Narrative
DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED EXCESS BLEEDING OCCURRED DURING USE OF THE CIRCUMCISION CLAMP. DEROYAL: THE SUPPLIER'S INVESTIGATION DETERMINED THAT LOTS WERE BUILT OUT OF SPECIFICATION, RESULTING IN THE POTENTIAL FOR THE DEVICE TO NOT CLAMP THE SURGICAL SITE PROPERLY. DEROYAL HAD MADE A ONE TIME PURCHASE FROM (B)(4) AND HAS DETERMINED TO CONDUCT A VOLUNTARY RECALL OF ALL PRODUCT PURCHASED FROM THEM. ANY PRODUCT REMAINING IN INVENTORY HAS BEEN QUARANTINED FOR DESTRUCTION, AND INITIAL RECALL LETTERS HAVE BEEN SENT TO AFFECTED CUSTOMERS.
Description of Event or Problem
THE HOSPITAL REPORTED EXCESS BLEEDING OCCURRED DURING USE OF THE CIRCUMCISION CLAMP.
Remedial action
- Recall