NEURO-SP-1/2X1/2"-STRL 20/CS
Received Jul 14, 2026 · Event occurred May 1, 2026
Report 1060680-2026-00011 · MDR key 25810892
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-054Lot number
25041059
Product problems
- Material Disintegration
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED THROUGH A FDA MEDWATCH, "RADIOPAQUE STRING ON 0.5 INCH X 0.5 INCH SPONGE BECAME DISCONNECTED FROM SPONGE WHILE IN USE. ALL PIECES WERE ACCOUNTED FOR." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS STATED IT WAS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A USER FACILITY REPORTED THROUGH A FDA MEDWATCH, "RADIOPAQUE STRING ON 0.5 INCH X 0.5 INCH SPONGE BECAME DISCONNECTED FROM SPONGE WHILE IN USE. ALL PIECES WERE ACCOUNTED FOR."