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Catalog Number 0400820000 |
Device Problems
Material Separation (1562); Torn Material (3024); Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/03/2018 |
Event Type
malfunction
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Event Description
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It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
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Manufacturer Narrative
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Device was not returned.
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Event Description
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It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
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Search Alerts/Recalls
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