MAUDE Adverse Event Report: JULIUS ZORN, INC JUZO GARMENTS SLEEVLESS GARMENTS; COMPRESSION GARMENTS

Model Number 3021

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problems Swelling (2091); Swollen Lymph Nodes (2093)

Event Type  Injury  

Event Description

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).

• Brand Name: JUZO GARMENTS SLEEVLESS GARMENTS
• Type of Device: COMPRESSION GARMENTS
• Manufacturer (Section D): JULIUS ZORN, INC
• MDR Report Key: 4645404
• MDR Text Key: 5599125
• Report Number: MW5041724
• Device Sequence Number: 1
• Product Code: EYQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/25/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3021
• Other Device ID Number: R18713
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 50