BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 38084 · Received September 13, 1996

    Report

    Report Number
    2125050-1996-00454
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    October 14, 1995
    Report Date
    September 13, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE RECEIVED INFORMATION THE PHYSICIAN STATED THAT "POST-OPERATIVELY, THE PATIENT DEVELOPED PENILE SWELLING AND ARTHEMA, SCROTUM WITH SIGNIFICANT SUBCUTANEOUS INDURATION AND A CONSIDERABLE AMOUNT OF TENDERNESS AROUND THE PUMP." THE PHYSICIAN ALSO STATED THAT THE "SKIN OF THE SHAFT OF THE PENIS WAS RED AND EDEMATOUS, SCROTAL SKIN WAS RED BUT PRESENCE OF RUGAE." THE PHYSICIAN FURTHER STATED THAT ON 8/8 THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS AND WHIRLPOOL THERAPY. THE PHYSICIAN STATED THAT THE PATIENT WAS OBSERVED, MAKING TREATMENT AND SUBSEQUENT REMOVAL OF THE DEVICE ON 10/14/96, DIFFICULT. THE PATIENT IS ALSO DIABETIC. AT THE TIME OF THE EXPLANT PROCEDURE THE PHYSICIAN STATED THAT "THERE WAS PURULENCE SURROUNDING THE PUMP AND PURITENCE COMMING FROM THE LEFT CYLINDER ALONG THE TUBING," AND THAT THERE WAS "NECROTIC CORPOREAL TISSUE" PRESENT. ENTEROCOCCUS ORGANISMS WERE FOUND IN THE CULTURES TAKEN FROM THE WOUND. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF INFECTION, QA DID NOT PERFORM A MICROSCOPIC EXAMINATION. BASED ON THE PHYSICIAN'S OBSERVATIONS QA ACCEPTS THE REPORT OF INFECTION AS THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS BY QUALITY ASSURANCE INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, QA CONCLUDES THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. REPORTS OF THIS NATURE ARE NO MORE FREQUENT OR SEVERE THAN WHAT IS STATED IN THE LABELING OR USUAL FOR SERVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO AN "INFECTION". THE ENTIRE DEVICE WAS REMOVED. THE PHYSICIAN'S OPERATIVE NOTES STATE, "POST-OPERATIVELY, THE PATIENT DEVELOPED PENILE SWELLING AND ERYTHEMA, SCROTUM WITH SIGNIFICANT SUBCUTANEOUS INDURATION AND A CONSIDERABLE AMOUNT OF TENDERNESS AROUND THE PUMP. SKIN OF THE SHAFT OF THE PENIS WAS RED AND EDEMATOUS, SCROTAL SKIN WAS RED BUT PRESENCE OF RUGAE". DURING THE COURSE OF THE PROCEDURE TO REMOVE THE DEVICE IT WAS STATED,... "THERE WAS PURULENCE SURROUNDING THE PUMP AND PURULENCE COMING FROM THE LEFT CYLINDER ALONG THE TUBING". ..."NECTROTIC CORPOREAL TISSUE" WAS ALSO DISCOVERED. IT WAS ALSO CITED IN THE OPERATIVE NOTES THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL APPROXIMATELY TWO MONTHS POST-OPERATIVELY (NO SPECIFIC DATE WAS PROVIDED) AND..." PLACED ON INTRAVENOUS VENCOMY CIN AND PRIMAXIN. HE WAS ALSO BEGUN ON WHIRLPOOL THERAPY. PAIN, ERYTHEMA AND TENDERNESS GRADUALLY IMPROVED OVER THE COURSE OF HIS HOSPITALIZATION AND THERAPY. HE WAS DISCHARGED TO HOME MARKEDLY IMPROVED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90171/E90171/R90172

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention