FDA Adverse Event Other Summary report: N

BACK SURGERY

MDR report key: 4199072 · Received October 18, 2014

Report

Report Number
MW5038774
Event Type
Other
Date Received
October 18, 2014
Report Date
October 18, 2014
Product Code
HWC
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MS, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

THIS IS ON BEHALF OF SOMEONE THAT I LOVE VERY DEARLY. MRS (B)(6) HAD SURGERY FOR HER BACK AT (B)(6) WHERE SHE HAS UPTO 18 SCREWS IN HER BACK. SHE USED TO FALL EVERY ONCE IN A WHILE; BEFORE THE SURGERY, IT HAS HAPPENED MORE FREQUENTLY SINCE. I HAVE WITNESSED THE SWELLING THAT HAS BEGAN SINCE HER SURGERY. IT GETS TO A POINT WHERE SHE CANNOT WALK FOR LONG DISTANCES. SHE HAS ALSO HAD LASIK EYE SURGERY WHERE SHE NOW STILL HAS TO WEAR GLASSES AND SHE HAS TO PUT EYE DROPS IN HER EYES ON A REGULAR BASIS FOR THE DRYNESS THAT NOW HAPPENS. SHE IS A SENIOR CITIZEN AND HAS WORKED HER ENTIRE LIFE AND IT SEEMS AS SHE HAS BEGUN TO BE SEEMINGLY TAKEN ADVANTAGE OF. I HAVE BEEN AROUND BEFORE THESE SURGERIES AND AFTER AND SHE SEEMED TO HAVE BEEN BETTER BEFORE. SHE WILL NOT COMPLAIN BECAUSE SHE IS NOT A SELFISH PERSON. THERE SEEM TO BE ISSUES THAT ARE NOT BEING ADDRESSED AS A RESULT OF THESE SURGERIES. SHE TAKES AROUND 20 MEDICINES EVERY MORNING. I JUST HAVE VERY SERIOUS CONCERNS ABOUT THE QUALITY OF LIFE THAT IS BEING LEFT AFTER BEING A HUMAN LIVING CADAVER AND THE PROBLEMS STILL CONTINUE AND THERE HAS BEEN SO MUCH BILLED FOR THESE SURGERIES. I JUST HAVE CONCERNS. SHE WAS TESTED AND GIVEN SURGERY AT (B)(6) FOR HER BACK, YOU CAN CONTACT HER FOR WHERE THE LASIK WAS CONDUCTED. I DO NOT HAVE EXACT DATES BUT MAY BE SHE WILL SPEAK UP IF SOMEONE CONTACTS HER. THINGS DOWN IN (B)(6) ARE VERY HARD TO GET WELL ACTUALLY THE ENTIRE (B)(6) AREA. SAME PT AS MW5038773. DIAGNOSIS OR REASON FOR USE: MAJOR BACK PROBLEMS. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
664131 BACK SURGERY SCREW HWC

Patients

Seq Age Sex Outcome Treatment
1 74 YR Other