SPONGE NEURO 10 STRIPS XRAY, 1 X 6
Received May 11, 2026 · Event occurred Apr 21, 2026
Report 1060680-2026-00008 · MDR key 25136647
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-302NSLot number
25093075
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DISTRIBUTING FACILITY REPORTED, "IT WAS NOTED THAT THE STRINGS OF THE LONG SLIM PATTIES COMPONENT DETACHED WHEN PULLED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS LISTED AS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE 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 DISTRIBUTING FACILITY REPORTED, "IT WAS NOTED THAT THE STRINGS OF THE LONG SLIM PATTIES COMPONENT DETACHED WHEN PULLED."