Device Problem
Insufficient Information (3190)
|
Patient Problems
Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572); Insufficient Information (4580)
|
Event Date 05/01/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
|
|
Manufacturer Narrative
|
Date of event: unknown, used the first day of the aware month.
|
|
Event Description
|
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
|
|
Manufacturer Narrative
|
B3 date of event: unknown, used the first day of the aware month.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
|
Event Description
|
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.
|
|
Manufacturer Narrative
|
B3 date of event: unknown, used the first day of the aware month.
|
|
Event Description
|
It was reported that, following rezum therapy for benign prostatic hyperplasia, this patient experienced recurrent urinary tract infections and sediment in his urine.One infection progressed to sepsis.It was noted that these issues may have led to development of a retrourethral fistula.Upon examination, no fistula was found, but a large prostatic cavity was identified.A suprapubic catheter was inserted to allow the cavity to heal.Approximately four months later, cystoscopy was performed.The cavity had reduced in size and scarring was noted in the urethra.Inspection of the bladder neck did not find evidence of scar contracture.Inspection of the bladder found no stones, tumor or lesions.A transurethral resection of the prostate (turp) procedure was performed the following month.Following the turp procedure, hematuria was identified and the patient reported he was stlll incontinent.
|
|
Manufacturer Narrative
|
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
|
Manufacturer Narrative
|
B3 date of event: unknown, used the first day of the aware month.There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
|
Event Description
|
It was reported that the patient had a rezum procedure and sustained permanent injuries to the prostate and or bladder and or bladder neck.The patient was unable to control his ability to urinate.The patient had further surgeries to place a suprapubic tube to drain urine from his bladder.The patient also suffered from frequent, multiple and chronic urinary tract infections, including sepsis.No further information is known at this time.Additional information reported that the patient alleges he was left incontinent following the rezum procedure on (b)(6) 2021.
|
|
Search Alerts/Recalls
|