NEURO SPNG-1/2X3"-STRL- 20/CS
Received Mar 30, 2026 · Event occurred Mar 24, 2026
Report 1060680-2026-00007 · MDR key 24729316
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-057Lot number
25009312
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED, "THEY HAD A COTTONOID THAT BASICALLY FELL APART DURING A CASE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE BUT IT WAS LISTED AS NOT AVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). THE 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, "HAD A COTTONOID THAT BASICALLY FELL APART DURING A CASE."