Catalog Number PWF030 |
Device Problems
Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
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Patient Problems
Skin Discoloration (2074); Ulcer (2274); Pressure Sores (2326)
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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 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.The device was not returned.
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Event Description
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It was reported that the patient experienced a stage ii pressure ulcer to the perianal skin and labia bilaterally.The skin was assessed and the catheter was changed at least once a shift (q12hr), and more frequently when stooling.Redness was noted the morning of (b)(6) (day#6), subsequently, the catheter was removed.A skin care rn was consulted, who noted the skin injury occurred to the perianal skin and labia bilaterally, which mirrored where the rigid part of the purewick catheter that was in contact with the skin.The use of the purewick catheter was discontinued and the use of incontinence pads resumed.Once removed, the skin was monitored, however no dressing interventions were done.The purewick recommendations were to 'replace every 8-12 hours or if soiled with feces or blood.Assess skin for compromise and perform perinal care prior to placement of a new purewick femal external catheter.'the purewick recommendations were followed, however further review of purewick materials recommended q2hr removal of the device and skin assessment, which was not done for this patient.It was later reported that the suction was set to 60mmhg while in use.No medical intervention reported.
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Manufacturer Narrative
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Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
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Event Description
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It was reported that the patient experienced a stage ii pressure ulcer to the perianal skin and labia bilaterally.The skin was assessed and the catheter was changed at least once a shift (q12hr), and more frequently when stooling.Redness was noted the morning of 6/6 (day#6), subsequently, the catheter was removed.A skin care rn was consulted, who noted the skin injury occurred to the perianal skin and labia bilaterally, which mirrored where the rigid part of the purewick catheter that was in contact with the skin.The use of the purewick catheter was discontinued and the use of incontinence pads resumed.Once removed, the skin was monitored, however no dressing interventions were done.The purewick recommendations were to 'replace every 8-12 hours or if soiled with feces or blood.Assess skin for compromise and perform perinal care prior to placement of a new purewick femal external catheter.'the purewick recommendations were followed, however further review of purewick materials recommended q2hr removal of the device and skin assessment, which was not done for this patient.It was later reported that the suction was set to 60mmhg while in use.No medical intervention reported.
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Search Alerts/Recalls
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