Model Number PWFX30 |
Device Problem
Biocompatibility (2886)
|
Patient Problems
Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
|
Event Date 10/23/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient experienced irritation which might have been caused by the purewick female external catheter.The nurse treated the patient with fluconazole.The redness and swelling seemed to have gone down after being treated.It was stated that the patient would try to use the purewick again after they were healed.The patient had been using purewick products for less than 30 days.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the patient was experiencing irritation that might have been caused by the purewick female external catheter.Nurse treated the patient with fluconazole.The redness and swelling seemed to have gone down after being treated.It was stated that the patient would try to use the purewick again after they were healed.The patient had been using purewick products for less than 30 days.Per follow up via phone on (b)(6) 2022, the user stated that the patient was prescribed with cefuroxime by the doctor to cure the urinary tract and yeast infection.The patient had been using the purewick again and everything was fine.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: discontinue use if an allergic reaction occurs.Precautions: always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Recommendations: assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood" h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Search Alerts/Recalls
|