Device Problem
Dent in Material (2526)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 12/20/2023 |
Event Type
Injury
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Event Description
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We have received information from one customer that their patients sustained serious injuries while using an arjo mattress.There are 9 cases of serious skin breakdown, which occurred in different locations of patients bodies.This is report number 1 of 9 that will be submitted.The customer alleged that the mattresses had a dip or there was a sensation of a hard surface.The customer placed the mattresses into circulation and they are still used by the patients.These are mattresses built of foam, which responds to the patient¿s weight and patient¿s are supported on this foam.The investigation into the alleged dip in the center of the mattress is ongoing.This report is fulfilled taking a conservative approach, following the serious injury reported.
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Manufacturer Narrative
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Investigation is ongoing.Once the investigation results are available a supplemental report will be submitted.H3 other text : mattress not tagged by the customer for evaluation.
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Manufacturer Narrative
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A female patient sustained a stage 3 to occipital (back of head) and pressure injury stage 4 to the right.Customer later admitted, that injuries to ears were not related to arjo product per the customer, but were caused by external devices.The investigation is ongoing, the gathered data are analyzed.When conclusion is reached from the data, a supplemental report will be provided.
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Manufacturer Narrative
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Arjo conducted pressure mapping testing on the sampled mattress and found no higher pressure point.The gathered data from the testing and the complaints are being compiled and analysed.Once the investigation conclusion is completed, a supplemental report will be provided.
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Search Alerts/Recalls
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