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
Urinary Tract Infection (2120); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 04/23/2022 |
Event Type
Injury
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Event Description
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It was reported that the purewick female external catheter caused urinary tract infection to the patient, so they no longer use it.It was noted that the patient had been using this product for longer than 90 days.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.The potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable".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: "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".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.H3 other text : the device was not returned.
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Event Description
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It was reported that the purewick female external catheter caused urinary tract infection to the patient, so they no longer use it.It was noted that the patient had been using this product for longer than 90 days.It was unknown what medical intervention was provided for urinary tract infection.Per follow up received via phone on (b)(6) 2022, it was stated that the patient had irritation when wearing the purewick female external catheters, slight swelling and it was uncomfortable.The patient did not use the purewick urine collection system anymore.
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Search Alerts/Recalls
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