STATLOCK SECUREMENT DEVICE

Additional Manufacturer Narrative

THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BROKEN STATLOCK PRO DEVICE WAS CONFIRMED BUT THE EXACT CAUSE COULD NOT BE DETERMINED FROM THE PHOTO THAT WAS RETURNED FOR EVALUATION. IN THE PHOTO, ONE STATLOCK PRO DEVICE CAN BE SEEN. THE DEVICE SHOWS NO SIGN OF USE, AND THE ADHESIVE LINING IS STILL ATTACHED. THE CLEAR PLASTIC PORTION AND PAD ON RIGHT WING OF THE STATLOCK DEVICE IS COMPLETELY BROKEN OFF FROM THE MAIN BODY OF THE DEVICE ALONG THE PLASTIC RIDGE ON THE WING. THERE ALSO APPEARS TO BE A PIECE OF PLASTIC THAT HAD BROKEN OFF AND IS MISSING FROM THE PICTURE. THE SITE OF THE BREAK IS UNEVEN AND WHAT APPEARS TO BE AN ADHESIVE RESIDUE CAN BE SEEN WHERE THE PLASTIC WAS PREVIOUSLY GLUED TO THE PAD. THE REMAINING PLASTIC OF THE BROKEN PIECE APPEARS TO STILL BE GLUED TO THE PAD. SINCE THE RETURNED PHOTO SHOWS A BREAK AND SEPARATION OF THE RETENTION DEVICE FROM THE PAD, THE COMPLAINT WAS CONFIRMED, HOWEVER, THE ROOT CAUSE IS UNKNOWN. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem

IT WAS REPORTED "REGARDING STATLOCK PRO¿S BREAKING WHERE THE STICKY PIECES STAY ON THE PATIENT AND THE PLASTIC COMES OFF. OR THE PLASTIC IS BREAKING." NO OTHER INFORMATION WAS PROVIDED.