RS-LFS LUMBAR FUNCTIONAL SYSTEM
Received Feb 6, 2009
Report 1644243-2009-00001 · MDR key 1311264
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Rupture
Narrative
Description of Event or Problem
PATIENT REPORTED TO SALES REPRESENTATIVE THAT THE RS-LFS LUMBOSACRAL BRACE IS RUPTURING HER BREAST IMPLANT. PATIENT WENT TO HER DOCTOR. MEDICAL RECORDS WERE REVIEWED FROM ATTENDING PHYSICIAN. THE SAME DAY VISIT, MENTIONS THAT THE RS MEDICAL ACCOUNT MANAGER HAD FITTED THE PATIENT WITH RS-LFS AND ACCORDING TO PATIENT, IT LATER CAUSED THE RIGHT BREAST IMPLANT TO RUPTURE. DOCTOR EXPLAINED TO PATIENT THAT LUMBOSACRAL BRACES ARE NOT CONTRAINDICATED IN PERSONS WITH BREAST IMPLANTS. PHYSICIAN'S NOTES STATE "(PATIENT) STATES THAT BACK BRACE MADE BREAST IMPLANT BURSTS BUT (RS MEDICAL ACCOUNT MANAGER) WAS NOT INFORMED THAT SHE HAD IMPLANTS. DR (PLASTIC SURGEON) STATED THAT BRACE COULD HAVE CAUSED RUPTURE".
Additional Manufacturer Narrative
DEVICE RELATED CAUSALITY OF THE REPORTED EVENT WAS NOT DETERMINABLE. PRODUCT WAS VISUALLY AND DIMENSIONALLY INSPECTED AND MET SPECIFICATIONS WITH NO APPARENT DAMAGE NOTED.