Model Number PWFX30 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Itching Sensation (1943)
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Event Date 07/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient had an infection and bad itching.Patient stated that they were using vagisil and it got better but then came back as soon as they started using the purewick female external catheters again.It was unknown if the purewick female external catheter contributed to 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 information provided by bd represents all 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 bd.The device was not returned.
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Event Description
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It was reported that the patient had an infection and bad itching.Patient stated that they were using vagisil and it got better but then came back as soon as they started using the purewick female external catheters again.It was unknown if the purewick female external catheter contributed to infection.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.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.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible ".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: "discontinue use if an allergic reaction occurs.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Assess device placement and patient¿s skin at least every 2 hours." the device was not returned.
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Search Alerts/Recalls
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