FDA Adverse Event
Malfunction
Summary report: N
NEURO SPNG-1/2X3"-STRL- 20/CS
MDR report key: 24729316
·
Received March 30, 2026
Report
- Report Number
- 1060680-2026-00007
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- March 24, 2026
- Report Date
- March 30, 2026
- Manufacturer
- MEDSORB DOMINICANA, S.A.
- Product Code
- EFQ
- UDI-DI
- 00749756035910
- PMA / PMN Number
- K791871
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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, MEDSORB DOMINICANA, S.A. 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 · 0
A USER FACILITY REPORTED, "HAD A COTTONOID THAT BASICALLY FELL APART DURING A CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787021 | NEURO SPNG-1/2X3"-STRL- 20/CS | GAUZE/SPONGE, INTERNAL | EFQ | MEDSORB DOMINICANA, S.A. | 30-057 | 25009312 | 00749756035910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |