FDA Adverse Event Injury Summary report: N

JUZO GARMENTS SLEEVLESS GARMENTS

MDR report key: 4645404 · Received March 25, 2015

Report

Report Number
MW5041724
Event Type
Injury
Date Received
March 25, 2015
Report Date
March 25, 2015
Manufacturer
JULIUS ZORN, INC
Product Code
EYQ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

LAST (B)(6) I WAS FITTED FOR DAY AND NIGHT GARMENTS AT (B)(6). I HAD TAKEN A FALL THIS WINTER AND WAS DOWN FOR A FEW WEEKS WHICH I THOUGHT CAUSED AND INCREASE IN MY SWELLING. SO I HAD MY PHYSICAL AND TOLD DOCTOR SWELLING FROM LYMPHEDEMA WAS WORSE AGAIN AND ASKED FOR A REFERRAL TO SEE THERAPIST AGAIN TO GO THROUGH TOTAL DECONGESTIVE THERAPY AGAIN. MY DOCTOR GAVE ME ONE THEY CALLED TO MAKE THE APPOINTMENT AND I TOOK OUT A BAG I KEEP ALL NOTES, EXERCISES, GARMENTS PAPERWORK AND SUN IN. I LOOKED AT THE TAGS FROM MY LAST ORDER AND THEY DID NOT MATCH. WHEN MY FITTER ORDERED THESE SHE ONLY ORDERED ONE ARM SLEEVE BUT YOU ARE ALWAYS SUPPOSED TO GET 2, TO ALTERNATE WEARING THEM. SO I CALLED HER AND SHE SAID SHE WOULD ORDER ANOTHER AND MAIL IT TO ME. IT FELT FUNNY WHEN I RECEIVED IT BUT PEOPLE WHO DO NOT SUFFER FROM THIS CONDITION DO NOT KNOW HOW MUCH PAIN IT CAN CAUSE WITH THE SWELLING. MY HUSBAND BOUGHT ME A (B)(6) LEATHER COAT IN (B)(6), NOW IT DOESN'T FIT ON MY ARM. SO I WORE IT AND SWELLING INCREASED AND NEXT FRIDAY I START BACK INTO LYMPHEDEMA THERAPY TO TRY TO GET THE SWELLING DOWN AND SEE IF I NEED STRONGER GARMENTS TO KEEP MY SWELLING DOWN. THE TWO GARMENTS SHE SENT ME WERE JUZO DYNAMIC SOFT IN-COMPRESSION-23-30 MMHG. THE SECOND GARMENT SHE SENT ME WAS A JUZO EXPERT-COMPRESSION 18/21, WHICH IS WAY BELOW WHAT I NEED SO IT DID NOT KEEP MY ARM STABLE AND IT GOT BIGGER. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
199032 JUZO GARMENTS SLEEVLESS GARMENTS COMPRESSION GARMENTS EYQ JULIUS ZORN, INC 3021
199033 JUZO COMPRESSION SLEEVELESS GARMENTS COMPRESSION GARMENTS EYQ JULIUS ZORN, INC 3021
199034 JUZO COMPRESSION SLEEVLES GARMENTS COMPRESSION GARMENTS EYQ JULIUS ZORN, INC 3551

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other TRIMETHOPRIM| HYDROCODONE| JUZO GAUNTLET AND GLOVE| MULTIVITAMIN| OXYBITNIN| VITAMIN C| MIRILAX| ALLEGRA| CLOTRIMAZOLE| ELI-PEN| ONDANSETRON| PROZAC| LASIX| BREAST FORM| SOLARIS NIGHT SLEEVE| JUZO DAY SLEEVES| TENS MACHINE| KINESOLOGY TAPE| SKIN PREP| IT STAYS GARMENT ADHESIVE| MONISTAT 7| VITAMIN E| ADDERALL| VITAMIN D| VALIUM| BITE GUARD TO PREVENT NIGHT GRINDING| TRAZADONE| PROBIOTIC MULTIVITAMIN| MASTECTOMY BRA| DIFLUCAN| CALCIUM