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 or material surface is rough, abrasive or uncomfortable ".It was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: "warnings: to avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter: having frequent episodes of bowel incontinence without a fecal management system in place: experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Recommendations: perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.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.Change suction tubing per hospital protocol or at least every thirty (30) days." 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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