MERITS VISION SPORT POWER WHEELCHAIR
Received Jul 28, 2023 · Event occurred Apr 8, 2023
Report 9680333-2023-00002 · MDR key 17412667
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE MENTIONED PRODUCT IN REPORT #: (B)(4), THE PLEURX BOTTLE & PLEURX DRAINAGE SYSTEM, IS MADE BY MERIT MEDICAL SYSTEMS (FDA REGISTRATION #: 3010665433), NOT BY MERITS HEALTH PRODUCTS INC. (FDA REGISTRATION #: 1058069). THE REPORTER HAS LINKED THE MENTIONED PRODUCT TO THE WRONG MANUFACTURER. THEREFORE, MERITS HEALTH PRODUCTS INC. WILL NOT TAKE ANY FURTHER ACTION OR FOLLOW-UP REGARDING THIS MATTER.
Description of Event or Problem
IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: DEFECTIVE. (B)(6) 2023 CALLED CUSTOMER TO FOLLOW UP ON REPORTED ISSUE. SPOKE WITH HUSBAND WHO ADVISED OF THE FOLLOWING DETAILS BELOW. HE EXPLAINED THAT CUSTOMER PASSED SOMETIME BETWEEN THE NIGHT BEFORE EASTER AND EASTER DAY. CUSTOMER DID NOT HAVE ANY ISSUES WITH PLEURX BOTTLE, OCCASIONALLY HAD ISSUES ONLY WITH THE ADHESIVE BEING SCRUNCHED UP TOGETHER BUT THEY WERE ABLE TO FLATTEN THEM OUT AND USE THEM WITHOUT ANY ISSUES. HUSBAND IS MILITARY AND PART OF SPECIAL OPERATIONS AND HAS EXTENSIVE MEDICAL TRAINING. HUSBAND ADVISED THE PLEURX DRAINAGE SYSTEM WAS EASY TO USE AND THE PATIENT DIED FROM STAGE 4 CANCER, THE DEATH WAS IN NO WAY CAUSED BY THE PLEURX PRODUCT. THERE WAS NO PT IMPACT AND NOTHING TO RETURN.