Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994)
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Event Date 04/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Actual event date is unknown.
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Event Description
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It was reported by the patient that is experiencing excruciating pain and leakage three months post convective radiofrequency water vapor thermal therapy procedure.Follow up with the facility indicated that the device performed as intended during procedure.The facility was unable to provide the current status of the patient as the patient has not contacted the facility about the pain and leakage.No further information is available.
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Event Description
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It was reported by the patient that is experiencing excruciating pain and leakage three months post convective radiofrequency water vapor thermal therapy procedure.Follow up with the facility indicated that the device performed as intended during procedure.The facility was unable to provide the current status of the patient as the patient has not contacted the facility about the pain and leakage.No further information is available.
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Manufacturer Narrative
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Actual event date is unknown.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, the patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Search Alerts/Recalls
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