BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MEDICAL - REDMOND_PRODUCT

    MDR report key: 22383588 · Received July 2, 2025

    Report

    Report Number
    3005445717-2025-00007
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 9, 2025
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K161768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS MDR IS BEING SUBMITTED TO CORRECT THE INCORRECT FDA REGISTRATION NUMBER THAT WAS PREVIOUSLY SUBMITTED UNDER UF/IMPORTER REPORT NUMBER # (B)(4): EMDR DATA FDA REGISTRATION NUMBER INDICATED: 0003015876 - MEDICAL (PHYSIO). EMDR DATA FDA REGISTRATION NUMBER SHOULD INDICATE: 3005445717 MEDICAL (JOLIFE AB). ADDITIONAL MFG NARRATIVE: A CLINICAL REVIEW WAS PERFORMED AND BASED ON THE LIMITED INFORMATION IS NOT POSSIBLE TO DETERMINE IF USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. DUE TO CHARACTER LIMITATIONS SECTION E1, INITIAL REPORTER PHONE, WAS LEFT BLANK. THE INITIAL REPORTER¿S PHONE NUMBER IS (B)(6). STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. STRYKER REQUESTS PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H10 HAS BEEN POPULATED WITH THE RELATED MDR # 0003015876-2025-01160.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT A UTERINE RUPTURE, IN A PREGNANT PATIENT, WAS OBSERVED FOLLOWING USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT A UTERINE RUPTURE IN A PREGNANT PATIENT WAS OBSERVED FOLLOWING USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT A UTERINE RUPTURE IN A PREGNANT PATIENT WAS OBSERVED FOLLOWING USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11136 UNKNOWN_MEDICAL - REDMOND_PRODUCT COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB - 3005445717 3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other