DEROYAL
Received Jan 23, 2014 · Event occurred Dec 20, 2013
Report 2320762-2014-00002 · MDR key 3608592
Device
Generic name
Fha - Clamp, Penile
Manufacturer
G.a. Surgical (pvt) LtdCatalog number
32-1622
Lot number
33444071
Product problems
- Product Quality Problem
Patient
Not reported
- Blood Loss
Narrative
Description of Event or Problem
THE MEDICAL CENTER REPORTED THAT THE GOMCO BELLS SEEM TO BE DEFECTIVE. THEY HAVE BEEN EXPERIENCING AN INCREASE IN NEWBORNS BLEEDING POST CIRCUMCISION BECAUSE THE BELL DOES NOT CLAMP PROPERLY.
Additional Manufacturer Narrative
DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT THE GOMCO BELLS SEEM TO BE DEFECTIVE. THEY HAVE BEEN EXPERIENCING AN INCREASE IN NEWBORNS BLEEDING POST CIRCUMCISION BECAUSE THE BELL DOES NOT CLAMP PROPERLY. DEROYAL: THE SUPPLIES'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 PRODUCTS PURCHASED FROM THEM. ANY PRODUCT REMAINING IN INVENTORY HAS BEEN QUARANTINED FOR DESTRUCTION, AND INITIAL RECALL LETTERS HAVE BEEN SENT TO AFFECTED CUSTOMERS.
Remedial action
- Recall