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Catalog Number MA2260-PM |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Skin Tears (2516)
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Event Date 09/22/2022 |
Event Type
malfunction
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Event Description
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It was alleged that, at the end of the surgical procedure (about 2 hours), the upper body warmer was taken off of the patient who was prone.As the warmer was removed, it was noticed that a lot of the drape where the adhesive was, was sticking to the patient.When clinical staff attempted to remove part of the drape that was stuck onto the patient (the adhesive part), the patients¿ skin came off.
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Event Description
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It was alleged that, at the end of the surgical procedure (about 2 hours), the upper body warmer was taken off of the patient who was prone.As the warmer was removed, it was noticed that a lot of the drape where the adhesive was, was sticking to the patient.When clinical staff attempted to remove part of the drape that was stuck onto the patient (the adhesive part), the patients¿ skin came off.
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Manufacturer Narrative
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Multiple attempts were made to contact this customer to obtain further information, however, no response was received.A review of previous similar complaints identified that this issue may have been due to a pre-existing skin condition which could result in a reaction to an adhesive applied to the skin, however this could not be confirmed.A stryker sr.Staff medical science liaison reviewed the information and stated that based on the event description the patient may have received over the counter medication and the injury was likely bandaged.H3 other text: device was not accessible for testing.
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Search Alerts/Recalls
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