Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Urinary Retention (2119)
|
Event Date 08/26/2020 |
Event Type
Injury
|
Event Description
|
It was reported that the patient did not present with an infection during convective radiofrequency water vapor thermal therapy, however the patient suffered an esbl e.Coli infection post procedure and was placed on iv antibiotics.A catheter was placed immediately post procedure but failed a void trial, and a new catheter was placed 1 week post procedure.The patient finished an additional 4 weeks course of iv antibiotics.The patient cultures were negative, however the infection persisted after the treatment.The patient still has irritative symptoms with significant urine urgency and frequency requiring a foley.The physician thinks the infection was catheter-associated.
|
|
Event Description
|
It was reported that the patient did not present with an infection during convective radiofrequency water vapor thermal therapy, however the patient suffered an esbl e.Coli infection post procedure and was placed on iv antibiotics.A catheter was placed immediately post procedure but failed a void trial, and a new catheter was placed 1 week post procedure.The patient finished an additional 4 weeks course of iv antibiotics.The patient cultures were negative, however the infection persisted after the treatment.The patient still has irritative symptoms with significant urine urgency and frequency requiring a foley.The physician thinks the infection was catheter-associated.
|
|
Manufacturer Narrative
|
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was not returned for analysis.A review of the product labeling determined that urinary retention and infection are noted as potential adverse events associated with the use of the device.Based on the available information, an evaluation conclusion code of known inherent risk of device was assigned to this event.
|
|
Search Alerts/Recalls
|