inforMED
InjuryGDY

DEROYAL

Received Oct 10, 2013 · Event occurred Sep 16, 2013

Report 3004605321-2013-00004 · MDR key 3435418

Device

Generic name

Gdy - Gauze/sponge, Internal, X-ray Detec

Catalog number

32-1581

Lot number

28634662

Product problems

  • Material Separation

Patient

Not reported

  • Tissue Damage

Narrative

Description of Event or Problem

THE HOSPITAL REPORTED THAT THE RADIOPAQUE ELEMENT SEPARATED FROM THE SPONGE. THE DOCTOR HAD TO REOPEN THE PATIENT TO BE SURE NO SPONGE WAS LEFT IN. WHEN ADDITIONAL PACKAGES WERE OPENED THE ELEMENT WAS JUST LAYING IN FOLD, NOT SEWN TOGETHER.

Additional Manufacturer Narrative

(B)(4): THE MANUFACTURER, JIANGUS GUANDGA MEDICAL MATERIAL GROUP CO., LTD., WAS NOTIFIED OF THE REPORTED ISSUE. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.