BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 17729169 · Received September 12, 2023

    Report

    Report Number
    2648988-2023-00028
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 29, 2023
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: A2, A3, B3, D9, G3, G6, H2, H3, H6, H10. THE BIOPATCH WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. MEDWATCH FORM RECEIVED (UNT-2023-020844). DATE OF THIS EVENT: 07/20/2023. DATE OF THIS REPORT: 07/28/2023. PATIENT IDENTIFIER: (B)(6). SEX: FEMALE. AGE: 47 YEARS. DATE OF BIRTH: (B)(6) 1976. LOT NUMBER: NOT REPORTED. ADVERSE EVENT OR PRODUCT PROBLEM: ADVERSE EVENT. SUSPECT PRODUCT(S): REMODULIN IV (TREPROSTINIL SODIUM) INJECTION, 2.5 MG/ML. DOSE, FREQUENCY & ROUTE USED:0.016 G/KG, THERAPY DATES: 2023 TO ONGOING 03/2021 TO ONGOING. DIAGNOSIS FOR USE: PAH (PULMONARY ARTERIAL HYPERTENSION). PAH (PULMONARY ARTERIAL HYPERTENSION). LOT NUMBER: NOT REPORTED. EVENT ABATED AFTER USE: DOESN'T APPLY. STOPPED OR DOSE REDUCED? EVENT REAPPEARED AFTER REINTRODUCTION? DOESN'T APPLY. CONTACT MANUFACTURER NAME: JUNITED THERAPEUTICS. ADDRESS: 55 T W ALEXANDER DRIVE, P.O. BOX 14186. RESEARCH TRIANGLE PARK, NC 27709 UNITED STATES. PHONE #: +1(919)485-8350. OTHER RELEVANT HISTORY: ONGOING, CURRENT CONDITION, PULMONARY ARTERIAL HYPERTENSION. DOSE, FREQUENCY & ROUTE USED: SUSPECT MEDICATION #1: 0.016 G/KG, CONTINUING, IV DRIP. SUSPECT MEDICATION #2: 40 MG ([QD] ONCE DAILY), ORAL USE. DIAGNOSIS FOR USE: ADHESIVE TAPE ALLERGY (DERMATITIS CONTACT). DRUG USE FOR UNKNOWN INDICATION (PRODUCT USED FOR UNKNOWN INDICATION). DRUG USE FOR UNKNOWN INDICATION (PRODUCT USED FOR UNKNOWN INDICATION). ADDITIONAL DOSAGE REGIMENS: SUSPECT PRODUCT: REMODULIN IV REG.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    CASE DESCRIPTION: "THIS 47-YEAR-OLD, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 2.5 MG/ML), ON AN UNREPORTED DATE IN (B)(6) 2023 FOR PULMONARY ARTERIAL HYPERTENSION (PAH). THE CURRENT DOSE WAS REPORTED AS 0.016 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON (B)(6) 2023, THE PATIENT HAD ALLERGIC TO THE CHLORHEXIDINE AND THE BIOPATCH SINCE IT IS IMBEDDED WITH IT, ITCHED WHICH IS EXPECTED WITH PLACING THE BIOPATCH THAT SHE SEEMS TO BE ALLERGIC TO OVER IT; IV SITE HAS BEEN ITCHING/HAS SOME SMALL BUMPS (ADHESIVE TAPE ALLERGY) AND TRIED USING BENADRYL WITH NO RELIEF (THERAPY NON- RESPONDER). CO-SUSPECT MEDICATIONS INCLUDED: ADCIRCA (TADALAFIL), BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE), AND BIOPATCH (CHLORHEXIDINE GLUCONATE). CONCOMITANT MEDICATION INCLUDED: OPSUMIT (MACITENTAN). RELEVANT MEDICAL HISTORY INCLUDED: PULMONARY ARTERIAL HYPERTENSION (PAH). AS PER THE REPORT RECEIVED ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT'S IV SITE HAD BEEN ITCHING/HAD SOME SMALL BUMPS BUT DENIED ANY PAIN, REDNESS, SWELLING, OR DISCHARGE. THE PATIENT HAD HER CURRENT SITE FOR ABOUT A WEEK. SHE HAD TRIED USING BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) WITH NO RELIEF (THERAPY NON- RESPONDER) AND ADVISED THAT PATIENT TRIED HYDROCORTISONE CREAM ON THE ITCHING THIS (B)(6) 2023 IN THE EVENING, SO SHE WAS NOT WAKING UP AND TRIED TO SCRATCH THE AREA. FURTHER, (B)(6) 2023, THE NURSE SPOKE WITH THE PATIENT'S DAUGHTER AND BELIEVED THAT THE PATIENT WAS ALLERGIC TO THE CHLORHEXIDINE AND THE BIOPATCH (CHLORHEXIDINE GLUCONATE) SINCE IT WAS IMBEDDED WITH IT AND THE ITCHING WHICH WAS EXPECTED WITH PLACING THE BIOPATCH THAT SHE SEEMED TO BE ALLERGIC TO OVER IT. SHE FURTHER REPORTED THAT SHE WAS NOT ON THE SITE, WHERE THE CORAM NURSE WAS. THE DAUGHTER REPORTED TO THE CNSS NURSE THAT THE CORAM NURSE STILL USED THE CHLORHEXIDINE TO CLEAN IT [SITE] AND THEN RINSED IT WITH SALINE AND STILL PLACED THE BIOPATCH. SHE ALSO MADE THE CNSS AWARE THAT THEY TOOK THE PATIENT TO THE EMERGENCY ROOM [ER] LAST NIGHT, (B)(6) 2023 DUE TO THE BAD ITCHING. THE NURSE WOULD BE MAKING THE PHARMACY AWARE ON NEEDED SUPPLIES ONCE PHYSICIAN OFFICE RESPONDS. ACTION TAKEN WITH IV REMODULIN AND ADCIRCA WAS DOSE NOT CHANGED DUE TO THE EVENT OF DERMATITIS CONTACT. AT THE TIME OF THE REPORTING, THE OUTCOME OF DERMATITIS CONTACT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY FOR THE EVENTS OF DERMATITIS CONTACT WITH IV REMODULIN. THE REPORTER'S CAUSALITY FOR THE EVENT OF DERMATITIS CONTACT WITH BIOPATCH WAS CONSIDERED TO BE POSSIBLY RELATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145971 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female