InjuryFMP
SAMMONS-PRESTON
Received Dec 29, 2025 · Event occurred Apr 10, 2024
Report 3004824601-2025-00183 · MDR key 23912594
Device
Product problems
- Inadequate Instructions for Healthcare Professional
- No Apparent Adverse Event
- Inadequate Instructions for Healthcare Professional
Patient
Not reported
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
ON (B)(6) 2024, CUSTOMER COMPLAINT WAS RECEIVED ON 081263565 ROLYAN POLYCUSHION PADDING, BEIGE, 1/8". CUSTOMERS COMPLAINED THAT IT SMELLED AND CAUSED SKIN REACTIONS ON TWO (2) OF THEIR CUSTOMERS.
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS.