MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle Spasm(s) (1966)
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Event Date 06/06/2019 |
Event Type
Injury
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Event Description
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The patient was given a prostate block, anti-anxiety and pain medication.During procedure, a total of 9 treatments were delivered.No device observation or adverse events cored during the procedure.It was reported that the same day post procedure, the patient started to experience bladder spasm for which toviaz and uribel (dose unknown) were administered.The symptom resolved 6 days post onset symptom.The investigator assessment of the patient bladder spasm symptom was assessed as definitely related to the treatment and not device related.The clinical end point committee (cec) adjudicated the patient symptom to definite treatment related and possible device related.
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Manufacturer Narrative
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The device is not available for analysis.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, an evaluation conclusion code of adverse event related to procedure was assigned to this investigation.
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Event Description
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The patient was given a prostate block, anti-anxiety and pain medication.During procedure, a total of 9 treatments were delivered.No device observation or adverse events cored during the procedure.It was reported that the same day post procedure, the patient started to experience bladder spasm for which toviaz and uribel (dose unknown) were administered.The symptom resolved 6 days post onset symptom.The investigator assessment of the patient bladder spasm symptom was assessed as definitely related to the treatment and not device related.The clinical end point committee (cec) adjudicated the patient symptom to definite treatment related and possible device related.
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Search Alerts/Recalls
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