The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".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: "precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter".It also states "recommendations: ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewick tm female external catheter prior to ambulation.Properly placing the purewick tm female external catheter snugly between the labia and gluteus holds the purewick tm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.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".
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