SAMMONS-PRESTON
Received Dec 18, 2025 · Event occurred May 5, 2023
Report 3004824601-0250-00210 · MDR key 23837176
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
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 ORIGINAL PRODUCT SPECIFICATION (PS) DID NOT EXPLICITLY DEFINE A WIDTH REQUIREMENT, AS THIS WAS CONSIDERED A NON-CRITICAL ATTRIBUTE AT THE TIME OF RELEASE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS OMISSION. THE PRODUCT IS NO LONGER DISTRIBUTED.
Description of Event or Problem
ON (B)(6) 2023, CUSTOMER COMPLAINT WAS RECEIVED ON A545802 ROLYAN SHOULDER IMMOBILIZER(M). CUSTOMER COMPLAINED THAT THE VELCROSTRAP CAUSED ABRASION ON THE SKIN OR FABRIC OF THE WEARER'S SHIRT BY BEING WIDER THAN THE ACTUAL STRAP. THEIR CLIENTS STATED THAT THE STRAP DID NOT USED TO BE THIS WIDE.