SAMMONS-PRESTON
Received Dec 17, 2025 · Event occurred Jan 9, 2023
Report 3004824601-2025-00203 · MDR key 23829012
Device
Product problems
- Inadequate Instructions for Healthcare Professional
- Inadequate Instructions for Healthcare Professional
Patient
NA · Unknown
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
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. THE INVESTIGATION CONCLUDED THAT AN UPDATE TO THE INSTRUCTIONS FOR USE (IFU) WAS REQUIRED TO PROVIDE GUIDANCE ON PROPER PRODUCT PLACEMENT TO PREVENT POTENTIAL INJURIES. ADDITIONALLY, A PRODUCT IMPROVEMENT WAS IMPLEMENTED TO INCORPORATE A MEDICAL-GRADE ADHESIVE IN THE EVENT THE ADHESIVE COMES INTO CONTACT WITH SKIN.
Description of Event or Problem
ON (B)(6) 2023, CUSTOMER COMPLAINT WAS RECEIVED ON 081419258 ROLYAN POLYCUSHION PADDING, BLACK, 1/8" ROLYAN POLYCUSHION PADDING, BLACK, 1/8". CUSTOMERS COMPLAINED THAT IT DETACHES FREQUENTLY, CREATING DISCOMFORT FOR PATIENTS THAT USE THE ORTHOTIC DEVICE. THEY ALSO REPORTED THAT THIS ISSUE CREATES AN EYESORE WHEN THE MATERIAL DETACHES.