BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOP INTRAOPERATIVE ELECTRON RADIATION THERAPY

    MDR report key: 14914733 · Received July 1, 2022

    Report

    Report Number
    MW5110661
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 22, 2022
    Report Date
    June 24, 2022
    Manufacturer
    INTRAOP MEDICAL CORP.
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUBJECT IS A 56 Y/O WHITE MALE WITH RECURRENT LARYNGEAL SQUAMOUS CELL CARCINOMA. SUBJECT WAS ENROLLED AND RANDOMIZED TO ARM B OF (B)(4) : HNSALV TRIAL: COMBINING IMMUNOTHERAPY WITH SALVAGE SURGERY AND IORT FOR TREATMENT OF PERSISTENT / RECURRENT HEAD AND NECK CANCERS. ON (B)(6) 2022, SUBJECT BEGAN WEEK 1 (C1D1) PRE-OPERATIVE PEMBROLIZUMAB (200MG) PER PROTOCOL. SUBJECT RECEIVED WEEK 4 PLANNED EBRT (2X 2GY FRACTIONS) ON (B)(6) 2022 AND (B)(6) 2022. PER VISIT WITH DR. (B)(6) (RAD ONC) ON (B)(6) 2022 , SUBJECT WITH SWELLING ALONG THE LEFT NECK AND PRESCRIBED MEDROL DOSE PACK ( (B)(6) 2022). ON (B)(6) 2022, SUBJECT UNDERWENT MRI NECK, WHICH SHOWED PROGRESSION OF THE DISEASE COMPARED TO PRIOR MRI ( B)(6) 2022). AFTER INTERDEPARTMENTAL REVIEW, THE SUBJECT'S SALVAGE SURGERY WITH IORT WAS SCHEDULED FOR EARLIER THAN PLANNED. SURGERY WITH IORT WAS CONDUCTED ON (B)(6) 2022 (WEEK 5) TO PRIORITIZE PATIENT SAFETY. SUBJECT RECEIVED CERVICAL TRACHEAL RESECTION, IORT, TUBED ALT, FLEXHD TO NECK, SALIVARY BYPASS TUBE PLACEMENT, PEG TUBE PLACEMENT AND WAS DISCHARGED ON (B)(6) 2022. ON (B)(6) 2022, PATIENT PRESENTED TO ED WITH CONCERN FOR WOUND DEHISCENCE AND PURULENT DRAINAGE FROM THE FLAP SITE CONCERNING FOR INFECTION; MILD ERYTHEMA/PAIN AND CHILLS ALSO ENDORSED BY SUBJECT. SUBJECT WAS ADMITTED ON (B)(6) 2022 (STUDY TEAM MADE AWARE OF THE EVENT (B)(6) 2022). (B)(6) 2022 BACTERIAL CULTURE AND DIRECT SMEAR OF WOUND DRAINAGE REVEALED HEAVY GROWTH OF ENTEROCOCCUS FAECALIS, HEAVY GROWTH OF KLEBSIELLA OXYTOCA, AND HEAVY GROWTH OF ESCHERICHIA COLI, (B)(6) 2022 BLOOD CULTURE WITH NO GROWTH ON DAY ONE OF FIVE. UNASYN (3G Q6H) INITIATED (B)(6) 2022. ADDITIONAL BACTERIAL CULTURE AND DIRECT SMEAR OF ABSCESS FLUID/SWAB COMPLETED (B)(6) 2022 REVEALING LIGHT GROWTH OF GRAM-NEGATIVE BACILLI, LIGHT GROWTH OF STENOTROPHOMONAS MALTOPHILIA, AND LIGHT GROWTH OF ESCHERICHIA COLI AND LIGHT GROWTH OF ENTEROCOCCUS FAECALIS. CURRENT PLAN OF CARE INCLUDES ONGOING LOCAL WOUND CARE, BID XEROFORM DRESSING CHANGES, AND ONGOING UNASYN TREATMENT. THE PROTOCOL TREATMENT REGIMEN WAS CONTINUED. DRUG WAS NOT MODIFIED. OUTCOME: THE SUBJECT CONTINUES TO EXPERIENCE WOUND INFECTION. PER INVESTIGATORS ((B)(6)) REVIEW OF REPORT SOURCE WOUND INFECTION, ATTRIBUTIONS ARE AS FOLLOWS: RELATION TO PRE-OPERATIVE PEMBROLIZUMAB: UNRELATED; RELATION TO EBRT: UNLIKELY; RELATION TO SALVAGE SURGERY: DEFINITELY RELATED ; RELATION TO IORT: UNLIKELY, PER TREATING PHYSICIANS, DR. (B)(6) AND DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449082 INTRAOP INTRAOPERATIVE ELECTRON RADIATION THERAPY SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN INTRAOP MEDICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization ACETAMINOPHEN 160MG/5ML SOLUTION-01/2018 - PRESENT| AMOXICILLIN-CLAVULANATE 875-125 MG TAKE 1 TAB PER G TUBE ROUTE: EVERY 12 HRS FOR 7 DAYS-6/15/2022-6/22/2022| AMOXICILLIN-CLAVULANATE (AUGMENTIN) 875-125 MG 1 TAB EVERY 12 HRS-6/12/2022-6/16/2022| BACITRACIN-POLYMYXIN B (POLYSPORIN) 500-10000 UNIT/GM OINTMENT AS NEEDED| BACITRACIN/POLYMYXIN(POLYSPORIN) OINTMENT 1 APPLICATION 2/DAY-6/7/2022-6/9/2022| EXTERNAL BEAM RADIATION THERAPY| FIRST-BLM MOUTHWASH (COMMERCIAL CONTAINING DIPHENHYD-LIDOCAINE-AL/MGHYDR-SIMETH)-01/2018 - PRESENT| GABAPENTIN SOLUTION ORAL SOLUTION (6 ML AT BEDTIME X2 DAY. THEN 6ML TWICE DAILY X2 DAY. THEN 12 ML 2/DAY X 2 DAYS, THEN 18 ML 2/DAY X2 DAYS. THEN 18 ML 3/DAY). -6/1/2022 - PRESENT| LEVOTHYROXINE 125 MCG TAB DAILY-01/2018 - PRESENT| MELOXICAM 15MG TAB DAILY-01/2019 - PRESENT| METHYLPREDNISOLONE 4 MG TAB THERAPY PACK TAB (MEDROL DOSPACK) FOLLOW AS DIRECTED ON PACKAGING-6/1/2022-PRESENT| NYSTATIN 100000 UNIT/ML ORAL SUSPENSION SWISH AND SWALLOW 10 ML 3/DAY FOR 21 DAYS (PT TAKING DIFFERENTLY: SWICH AND SWALLOW 1,000,000 UNITS 3 TIMES DAILY AS NEEDED)-01/2022 - PRESENT| OMEPRAZOLE 40 MG DR CAP, AT BEDTIME-01/2018 - PRESENT| OXYCODONE 5MG 2 TABS EVERY 4 HRS AS NEEDED FOR PAIN FOR 7 DAYS-04/11/2022-PRESENT| PEMBROLIZUMAB 200MG INTRAVENOUSLY - ONCE (PRE-OP), MFR: MERCK, LOT UNK. | REMEDY CREAM APPLY TO SKIN AS NEEDED-6/3/2022-PRESENT| SENNA SENOKOT) TAB 8.6 MG 2/DAY-NG TUBE-6/7/2022-6/16/2022| TRAMADOL 50MG TAB, TAKE 1 TAB ORAL EVERY 6 HRS AS NEEDED FOR 7 DAYS (PT IS NO LONGER TAKING)-04/01/2022-04/11/2022