inforMED
MalfunctionEFQ

NEURO-SP-1/2X1/2"-STRL 20/CS

Received Feb 11, 2026 · Event occurred Feb 6, 2026

Report 1060680-2026-00005 · MDR key 24314335

Device

Generic name

Gauze/sponge, Internal

Model number

30-054

Lot number

24102694

Product problems

  • Material Separation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A DISTRIBUTING FACILITY REPORTED, "STRING OF THE PATTY COME OFF OF THE ACTUAL PAD." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED A PICTURE, BUT HAS NOT YET RECEIVED THE ACTUAL DEVICE YET. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. 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, "STRING OF THE PATTY COME OFF OF THE ACTUAL PAD."