Model Number PWFX30 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Rash (2033); Urinary Tract Infection (2120); Localized Skin Lesion (4542)
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Event Date 05/11/2022 |
Event Type
Injury
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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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Event Description
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It was reported that the patient experienced a urinary tract infection, rash and lesions while using the purewick female external catheter.Once patient stopped using, all the problems seemed to go away.It was noted that the patient had been using the products for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection and no medical intervention was reported for rash and lesions.
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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 was 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 lot number was 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.Ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.Not recommended for patients who are: experiencing skin irritation or breakdown at the site".H11: section a through f - 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.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient experienced a urinary tract infection, rash and lesions while using the purewick female external catheter.Once patient stopped using, all the problems seemed to go away.It was noted that the patient had been using the products for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection and no medical intervention was reported for rash and lesions.
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Search Alerts/Recalls
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