MAUDE Adverse Event Report: JULIUS ZORN, INC. JUZO DYNAMIC COMPRESSION STOCKING, OPEN TOE 3511 TYPE AD SIZE IV 5CMSILICONE; STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Catalog Number PART NUMBER 16865 20-30 MMHG

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994); Swelling/ Edema (4577)

Event Date 05/07/2017

Event Type  Injury  

Event Description

Medical compression stockings manufactured by juvo (model 3511, type ad, size iv, dynamic, knee, ot, 5 cm, silicone, 20-30 mmhg).A manufacturing change sometime around or before this date resulted in the stockings being made too short.Example: length measurement from top cuff below the knee to heel now became the entire stocking length from top cuff-to-heel-to-end-of-open-toe-stocking (end is supposed to be along ball of foot from big to little toe).Since this reduction of size, cuff pulls down and wears at lower mid-calf causing extreme swelling above cuff to knee and extreme pain during normal 12-16 hour day wear time, and heel-to-ball-of-foot pulls back to heel-to-mid-arch causing extreme pain from arch to and including toes due to extreme swelling of end of foot (rounded like balloon) and extreme swelling of toes (extreme swelling of toes to 2-3 times normal diameter).The cuff-to-knee swelling also turns red, but the swelling of mid-arch-to-toes turns red to purple due to stopping blood flow and pooling of blood in swollen tissues, requiring hours of hand compressions of foot and upper calf to squeeze out blood which is almost coagulated.I am very afraid this will result in tissue death requiring amputation of end of foot/feet from arch to toes.The medical supply company, (b)(6), hospice and medical supplies, (b)(6) stores, is where i have received my juzo compression stockings since i began wearing them in 2010.For three years, 2017 to 2020, every technician blindly stated this was correct, ignoring the length change i would show them.Finally, technician (b)(6) (currently at the (b)(6)), ordered another two pair for me, for free, finally compared older stockings with newer stocking, verifying the length shortening, and verifying all model, style, et cetera were the exact same as i had always received and verifying these are correct for my leg and foot measurements, but the actual stockings are too short.He stated to me that the german manufacturer changed their manufacturing (unspecific if it was revamping the facilities, new facilities, or what the change was) sometime before may 2017.He tried contacting the us representatives (juzo usa, (b)(4)www.Juzousa.Com), but as i am guessing since i received a fabricated report, they told or perhaps threatened him, i do not know, that these are correct and there is no problem even though he was specific about the problem.Next he told me he would come in late to call the german manufacturing facility and/or the main office, but 8 months later after no reply, i am guessing either imc manager[s]stopped him from calling, or the rep refused to give him the proper telephone numbers, or he became lazy and simply failed to call.The swelling of my worse left leg and foot resulted in my toes developing deep creases and i cannot move those toes much at all due to the swelling.(b)(6) even took detailed specific measurements for custom stockings to bypass this length inaccuracy, but my primary physician, dr.(b)(6), refused to okay this stating my insurance, medicaid and medicare, would not okay this without extreme detailing and paperwork of reasons, and would probably refuse this anyway.Another compression stocking manufacturer, making "sport" closed-toe colored, also are too small ((b)(6) gave me two pair, and each day i wear these the stockings are so tight that ending of each day the back & sides of my heels are red and bruised and my toes are cold and white from no blood flow).Help, my old stockings are almost worn out, with the few i have left.I wonder how many people have required foot amputations due to this wrong sizing.The ends of both feet are now bulbous arch to toes, requiring daily squeezing to reduce swelling.Please contact me for further information and details, and please reply in any case.Multiple sizing and length done comparing to stocking of wrong size, by imc.All of my measurements are on file.My flip-phone cannot forward pictures nor download them to my computer or i would attach ones of my feet and the correct original and wrong new stockings, however, i can send them by text to you if you text me a contact number at my phone/text number included later/below.I really need the few correct stockings i have so it would be difficult to send them, but for a short time not impossible.They are not stretched out, as several technicians and i was told the rep stated, but they are old and worn.You cannot pull and stretch stockings to proper length and expect them to stay in the proper place, though technicians and i was told the rep state that is what needs done, but they have obviously never worn compression stockings nor understand stretching returns to unstretched size whether for diameter or length, which is unfathomable to me by those supposedly knowledgeable but evidently untrained/unknowing.Colloquially, i have "turned red and blue in the face" attempting to calmly explain this truth to about ten technicians, three ordering specialists, five or so counter/order/receptionists giving me ordered stockings, and also some medical professionals, over and over and over again.As a past co-liaison to the fda as quality engineer for a medical device manufacturer, this seems to be my last and hopefully successful alternative action.I hope this does not also fall on deaf ears, this has been a so frustrating experience of being "blown off" by multiple people, for years now.And i do not want my feet amputated, nor anyone else's feet.Fda safety report id# (b)(4).

• Brand Name: JUZO DYNAMIC COMPRESSION STOCKING, OPEN TOE 3511 TYPE AD SIZE IV 5CMSILICONE
• Type of Device: STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
• Manufacturer (Section D): JULIUS ZORN, INC.
• MDR Report Key: 15249906
• MDR Text Key: 298334833
• Report Number: MW5111561
• Device Sequence Number: 1
• Product Code: FQL
• UDI-Device Identifier: 00640095168652
• UDI-Public: 640095168652
• Combination Product (y/n): N
• 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: 08/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PART NUMBER 16865 20-30 MMHG
• Device Lot Number: STOCK CODE 3511AD5SB IV
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 10 MG; CARVEDILOL 25 MG 2X DAILY; CPAP AT 18 PSI; FISH OIL ; GINKO BILOBA; GLASSES FOR NEAR-SIGHTEDNESS (SINCE AGE 8, NOW BIFOCAL); GLUCOSAMINE CHONDROITIN; MELOXICAM 15 MG (RARELY, 1 PER 2-4 WEEKS, FOR ARTHRITIS) ; MULTIVITAMIN ; NIACIN (SPECIFICALLY NICOTINIC ACID, NOT NIACINAMIDE, FOR GOOD CORE-TO-SURFACE BLOOD FLOW/PROPER WARMTH AND PROPER TEMPERATURE SENSING), ; RECTIV OINTMENT 0.4 MG (RARELY, AS NEEDED).; TAMSULOSIN 0.4 MG; VIT D; VITAMIN B-COMPLEX; WELLBUTRIN/BUPROPION SR 150 MG (FOR SMOKING CESSATION AND MAINTENANCE); ZINC
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White