FDA Adverse Event
Malfunction
Summary report: N
NEURO-SP-1/2X1/2"-STRL 20/CS
MDR report key: 24314335
·
Received February 11, 2026
Report
- Report Number
- 1060680-2026-00005
- Event Type
- Malfunction
- Date Received
- February 11, 2026
- Date of Event
- February 6, 2026
- Report Date
- February 11, 2026
- Manufacturer
- MEDSORB DOMINICANA, S.A.
- Product Code
- EFQ
- UDI-DI
- 00749756037242
- PMA / PMN Number
- K791871
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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 · 0
A DISTRIBUTING FACILITY REPORTED, "STRING OF THE PATTY COME OFF OF THE ACTUAL PAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378011 | NEURO-SP-1/2X1/2"-STRL 20/CS | GAUZE/SPONGE, INTERNAL | EFQ | MEDSORB DOMINICANA, S.A. | 30-054 | 24102694 | 00749756037242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |