BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIDA WEARABLE NEUROMODULATION SYSTEM

    MDR report key: 24285805 · Received February 7, 2026

    Report

    Report Number
    3021071-2026-00001
    Event Type
    Injury
    Date Received
    February 7, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 6, 2026
    Manufacturer
    EXODUS INNOVATIONS LTD.
    Product Code
    NAM
    UDI-DI
    07297539080174
    PMA / PMN Number
    K192731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATED POTENTIAL SOURCES OF PRODUCT TEXTILE FRAGRANCE AND IDENTIFIED THE DETERGENT AND FABRIC SOFTENER USED IN THE ESTABLISHED LAUNDERING PROCESS AS THE MOST PROBABLE SOURCES. DEVICE LABELING WAS REVIEWED AND REFERENCES THE USE OF COMMERCIAL DETERGENTS BUT DOES NOT PROVIDE A WARNING TO INDIVIDUALS WITH POTENTIAL SENSITIVITIES TO DETERGENTS OR ADDED FRAGRANCES. A CAPA WAS OPENED TO ADD AN ALLERGY WARNING TO THE LABELING.

    Description of Event or Problem · 0

    ON 09-JAN-2026 COMPLAINT # (B)(4). PATIENT AGED 37 WITH DOCUMENTED HISTORY OF URINARY URGE AND URINARY INCONTINENCE WAS PRESCRIBED ZIDA WEARABLE NEUROMODULATION DEVICE TO TREAT THESE SYMPTOMS. IMMEDIATELY UPON RECEIPT OF THE DEVICE ON (B)(6) 2026, THE COMPLAINANT REPORTED THAT UPON OPENING THE DEVICE PACKAGING, A STRONG FRAGRANCE WAS PRESENT ON THE SOCK. THE COMPLAINANT STATED SHE HAS A SEVERE FRAGRANCE ALLERGY AND AN AUTOIMMUNE CONDITION AFFECTING HER AIRWAY. SHE REPORTED EXPERIENCING AN ALLERGIC REACTION FOLLOWING EXPOSURE TO THE ODOR. THE DEVICE WAS NOT WORN OR USED. THE SOCK WAS ISOLATED AND PLACED IN A BAG. THE COMPLAINT WAS RECORDED AND DEEMED NOT TO REQUIRE MDR REPORTING BECAUSE THERE WAS NO INDICATION THAT THE ALLERGIC REACTION MET THE DEFINITION OF A SERIOUS INJURY. AN INVESTIGATION WAS OPENED AND FOUND THIS TO BE AN ISOLATED INCIDENT RELATED TO A PATIENT WITH UNIQUE CIRCUMSTANCES AND THE INITIAL INVESTIGATION WAS CLOSED. THE PATIENT LATER CONTACTED THE COMPANY VIA EMAIL (B)(6) 2026 AND STATED SHE HAS NOT ATTEMPTED TO LAUNDER THE SOCK AND MAY REQUIRE ASSISTANCE WITH WASHING INSTRUCTIONS. THE PATIENT INDICATED SHE DOES NOT INTEND TO BEGIN USING THE SOCK UNTIL MID TO LATE THE FOLLOWING WEEK. THE COMPLAINANT CONTACTED THE COMPANY AND REPORTED THAT DURING PRODUCT UNBOXING, THE PATIENT PERCEIVED A STRONG FRAGRANCE EMANATING FROM THE SOCK. THE PATIENT STATED SHE HAS A SEVERE FRAGRANCE ALLERGY AND IMMEDIATELY RETURNED THE SOCK TO THE PACKAGING TO LIMIT EXPOSURE. THE COMPLAINANT REQUESTED THAT THIS INFORMATION BE DOCUMENTED AND REPORTED. ON 20-JAN-2026 COMPLAINT # (B)(4): DURING A SUBSEQUENT PHONE CALL ON (B)(6) 2026, THE PATIENT REPORTED EXPERIENCING AN ALLERGIC REACTION WHICH SHE ATTRIBUTED TO THE FRAGRANCE ASSOCIATED WITH THE SOCK. THE PATIENT STATED SHE HAS AN AUTOIMMUNE CONDITION THAT AFFECTS HER AIRWAY. SHE FURTHER REPORTED RECENT HOSPITALIZATION AND AN ADDITIONAL EMERGENCY ROOM VISIT. DURING THIS CALL, THE PATIENT INDICATED SHE WAS ATTEMPTING TO CONTACT HER RHEUMATOLOGIST TO DETERMINE WHETHER FURTHER EMERGENCY MEDICAL EVALUATION WAS REQUIRED. THE PATIENT STATED THAT HER HEALTH AND RESPIRATORY STATUS WERE HER PRIMARY CONCERN AT THAT TIME. THE PATIENT CONFIRMED THAT THE SOCK REMAINS SEALED IN A BAG AND HAS NOT BEEN WASHED OR USED. AFTER LEARNING THAT THE SOCK WAS POTENTIALLY ASSOCIATED WITH AN EMERGENCY ROOM VISIT AND/OR HOSPITALIZATION, IT WAS DETERMINED THAT THE EVENT MET THE DEFINITION OF A SERIOUS INJURY AND WAS THEREFORE REPORTABLE. DEVICE RETURN STATUS: A PRE-PAID RETURN ENVELOPE WAS PROVIDED TO THE PATIENT FOR RETURN OF THE DEVICE FOR INVESTIGATION. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN SENT DESPITE THE PATIENT RECEIVING THE PREPAID ENVELOPE. PATIENT MEDICAL INFORMATION: PATIENT HAS RELAPSING POLYCHONDRITIS, MIGRAINES, PROBABLE AUTOIMMUNE PANCREATIS AND MICROSCOPIC LYMPHOCYTIC COLITIS, EXPERIENCED DVT, EXPERIENCED ADVERSE EVENTS RELATED TO ANTICHOLINERGICS AND CYMBALTA. PATIENT IS PRESCRIBED THE FOLLOWING DRUGS: TRILYTE, TRETINOIN, RIZATRIPTAN, LIDEX, PROZAC, EMGAILITY PEN, ATIVAN, MEDROL, EPINEPHRINE, HUMIRA. COMPLETE MEDICAL HISTORY AND LIST OF MEDICATIONS CAN BE FOUND IN CHARTS AND NOTES ATTACHED TO COMPLAINT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22530 ZIDA WEARABLE NEUROMODULATION SYSTEM ZIDA CONTROL SOCK NAM EXODUS INNOVATIONS LTD. 8017 2502006-1 07297539080174

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization ADDERALL 10 MG| ADDERALL XR 20 MG| ALBUTEROL 0.083% NEBULIZER SOLUTION| ATIVAN 0.5 MG TABLET| AZELAIC ACID 15% GEL| BREYNA 80- 4.5 MCG| DECADRON 1 MG TABLET| EMGALITY PEN 120 MG/ML| EPINEPHRINE 0.3 INJECTOR| HUMIRA PEN 40 MG| HYTONE 2.5% OINTMENT| INDERAL 10 MG TABLET| LIDEX 0.05% OINTMENT| LIDOCAINE 2% SOLUTION| MAXALT- MLT 10 MG| MEDROL 4 MG TABLET| OXYCODONE 5 MG| PROZAC 10 MG| PROZAC 20 MG| TEMOVATE 0.05% TOPICAL SOLUTION| TRETINOIN 0.025% CREAM| TRILYTE ORAL SOLUTION 420 GRAM| VITAMIN B6 50 MG