NEURO SPGS-1/2X6"-20/C
Received Jun 8, 2026 · Event occurred Sep 16, 2025
Report 1060680-2026-00010 · MDR key 25429916
Device
Generic name
Gauze/sponge, Internal
Manufacturer
Medsorb Dominicana, S.a.Model number
30-301Lot number
25051284
Product problems
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED THROUGH A FDA MEDWATCH, "ITEMS IN PACKAGE NOT UNIFORM IN SIZE." DEROYAL INDUSTRIES, INC. HAS REQUESTED RETURN OF THE DEVICE, HOWEVER IT HAS NOT YET BEEN RECEIVED. 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 THROUGH A FDA MEDWATCH, "ITEMS IN PACKAGE NOT UNIFORM IN SIZE."