MalfunctionITG
SPECIALIST(R) STERILE COTTON BLEND STERILE CAST PADDING
Received Apr 25, 2025 · Event occurred Apr 18, 2025
Report MW5169527 · MDR key 21911764
Device
Generic name
Bandage, Cast
Manufacturer
Bsn Medical, Inc.Model number
72345-02Catalog number
9044S
Lot number
318326
Product problems
- Material Disintegration
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PROVIDER HAD SIGNIFICANT ISSUES WITH THE STERILE 4X4 HONEYCOMB SPECIALIST COTTON BLEND CAST PADDING REF # 72345-02. THE HONEYCOMB PADDING WAS DISINTEGRATING WHEN BEING APPLIED TO THE KNEE. THIS IS THE CAST PADDING SIZE 6" STERILE CAST PADDING. PROVIDER STATES "IT DISINTEGRATES" AND IS "NOT ACCEPTABLE".