DYNASPLINT
Received Dec 11, 2012 · Event occurred Sep 19, 2012
Report MW5028076 · MDR key 2875398
Device
Generic name
Knee Extension Splint
Manufacturer
Dynasplint Systems, Inc.Product problems
- Inadequate Instructions for Healthcare Professional
- Inadequate Instructions for Non-Healthcare Professional
Patient
90 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NO PRODUCT INFORMATION, PROTOCOL, OR MANUFACTURER CONTACT DOCUMENTS WERE SUPPLIED WITH THE DEVICE. NO TRAINING WAS PROVIDED FOR THE SKILLED NURSING FACILITY STAFF. MANUFACTURER'S REP DID NOT SUPPLY ANY DOCUMENTS OR TRAINING FOLLOWING MULTIPLE REQUESTS. DEVICE RETURNED AFTER ONE MONTH, UNUSED TO PREVENT POSSIBLE INJURY, TO THE MANUFACTURER. DISCOVERED "PATIENT BILL OF RIGHTS" IN BOX JUST BEFORE SEALING FOR RETURN TO MANUFACTURER; NONE OF THE INFORMATION REFERRED TO IN THAT DOCUMENT WAS EVER RECEIVED BY THE PATIENT OR THEIR AGENT. BILLING DEPT. LETTER ARRIVED AT THE MAILING ADDRESS AS THE DEVICE WAS IN TRANSIT, SO THE MANUFACTURER HAD THE CORRECT ADDRESS TO SEND DOCUMENTS.