BLOM-SINGER
Received Nov 17, 2017 · Event occurred Oct 1, 2017
Report 2025182-2017-00007 · MDR key 7043087
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
70 YR
- Aspiration/Inhalation
- Aspiration/Inhalation
Narrative
Description of Event or Problem
ON (B)(6) 2017, THE PATIENT'S SPEECH LANGUAGE PATHOLOGIST (SLP) REPORTED A COMPLAINT OF AN ASPIRATED CLEANING BRUSH TIP. THE CLEANING BRUSH TIP BECAME DETACHED FROM THE HANDLE WHILE THE PATIENT WAS CLEANING THEIR VOICE PROSTHESIS. THE PATIENT DID NOT REALIZE THAT THEY HAD ASPIRATED THE PRODUCT. IN THE FOLLOWING WEEKS, THE PATIENT'S HEALTH DETERIORATED, AND AFTER REPEATED VISITS TO THE CLINIC, DOCTORS WERE ABLE TO CONCLUDE THAT THERE WAS A FOREIGN OBJECT LODGED IN THE PATIENT'S WINDPIPE. FOLLOW-UP WITH THE SLP INDICATED THAT THE ASPIRATION EVENT OCCURRED A FEW WEEKS BEFORE (B)(6) 2017; HOWEVER, THE SLP WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS ABOUT ANY TREATMENT OR INTERVENTION PERFORMED FOR THE PATIENT (E.G. REMOVAL). THE SLP DID INDICATE THAT THE PATIENT IS PRESENTLY IN A HEALTHY STATE. ADDITIONALLY, THE SLP INDICATED THAT THE CLEANING BRUSH WAS NOT AVAILABLE TO RETURN FOR EVALUATION.