MAUDE Adverse Event Report: BSN MEDICAL, INC. JOBST MEDICAL COMPRESSION STOCKING 15-20 MMHG SIZE MEDIUM CAT NO. 119179, BLACK ; STOCKING MEDICAL SUPPORT

Model Number BRN:7363711;BRN:7707502

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 07/14/2018

Event Type  Injury  

Event Description

Product manufacturer of jobst (brand) medical/compression stockings, bsn medical inc., (b)(4).Advise how i can get pics to you.In (b)(6) 2018, i was told by dr (b)(6) that i needed to wear compression stocking to protect a varicose vein in my l leg.I went to a local drug store, found and bought jobst thigh highs and wore them for about one week and i broke out in a severe allergic reaction to the silicone that is used in the band that holds the stocking up at the top of the thigh.I contacted dr (b)(6) and was told to stop wearing them and to look for an alternative compression stocking design.I then learned that there are pantyhose compression stockings that i assumed would remove the silicone band from the top of my thigh that is the design of the thigh high stockings.I began to wear the jobst pantyhose.On saturday (b)(6), i developed a severe allergic reaction to the pantyhose (substantially worse than the first reaction stated above) and now have a red rash and blisters all over my lower torso front, l torso side, upper l leg, especially where leg connects to torso, pubic area and my back around waist line.I have pics.I have been using prescribed cream, triamcinolone acetonide.1% since (b)(6) that i am using (2x daily) to treat my allergic reaction to latex/rubber/silicone prescribed by dr (b)(6).This severe allergic reaction to the jobst stockings has been extremely traumatic, life interrupting and painful.I had to request to work remotely for over 7 days because wearing clothes was outrageously painful.I can't sleep because this rash with blisters is on my back just below the waist line and about 2+ inches in height and 4+ inches in length, on my abdomen and throughout my pubic area and on my left leg at the top of the thigh and continuing around/across the top of the thigh about 2.5 inches in height and 5 inches in length and in my entire pubic area.It is painful to touch with one finger.The cream does seem to have helped, albeit very slowly.It has dried up the skin but the skin is still red and raw and likely will scar.The cream has caused most of the smaller blisters to dry up but the skin underneath where the blisters were is red, raw flesh not healthy normal skin.Living with this has caused me to ask my employer to allow me to work from home because putting on clothes over this rash is very uncomfortable and distracting and would cause the healing time to be slowed.After this allergic reaction, i have had, i did internet research and reactions like mine are posted on numerous compression stocking website forums; women with a severe silicone reaction from wearing compression is an established event/occurrence for other women.There are no product warnings on the box these stockings came in.This is outrageous that something this severe could happen to my body from wearing a pair of pantyhose.I had understood the fda was responsible for regulating medical devices.This product should not be on the market as it is not safe.How did this make it onto the market?.

• Brand Name: JOBST MEDICAL COMPRESSION STOCKING 15-20 MMHG SIZE MEDIUM CAT NO. 119179, BLACK
• Type of Device: STOCKING MEDICAL SUPPORT
• Manufacturer (Section D): BSN MEDICAL, INC.; charlotte NC
• MDR Report Key: 7772434
• MDR Text Key: 117009832
• Report Number: MW5079032
• Device Sequence Number: 1
• Product Code: LLK
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BRN:7363711;BRN:7707502
• Device Catalogue Number: 115505
• Device Lot Number: 126193646, 025240635
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 53