Model Number PWFX30 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Local Reaction (2035); Urinary Tract Infection (2120)
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Event Date 10/22/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient got a urinary tract infection while using the purewick female external catheter.It was stated that the patient seemed like an allergic reaction to the wick and the patient was currently using a foley catheter.The purewick supplies was purchased on (b)(6) 2021, and it had not been replaced since purchased.It was unknown what medical intervention was provided for urinary tract infection.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the patient got a urinary tract infection while using the purewick female external catheter.It was stated that the patient seemed like an allergic reaction to the wick and the patient was currently using a foley catheter.The purewick supplies was purchased on (b)(6) 2021, and it had not been replaced since purchased.It was unknown what medical intervention was provided for urinary tract infection.
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Search Alerts/Recalls
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