Model Number 31151010 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Erythema (1840); Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Event Description
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It was reported to covidien on (b)(4) 2014 that a customer had an issue with a head positioner.The customer reports that a patient had redness, burning, and blistering after use of the soft touch head positioner.The customer further reports that the patient was given silvadene with mepilex to cover the irritated area by the wound care nurse.
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Manufacturer Narrative
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Submit date: 1/05/2015.An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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A review of the device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.Device history records are reviewed and approved by quality prior to release of product.No samples were received for further evaluation; the customer reported that the samples were discarded.The most likely root cause is patient skin sensitization to the foam product.It should be noted that a biocompatibility study was performed for this product code with no skin tissue response at any time during the study period.Because the issue was not found to be attributable to a manufacturing issue, no corrective or preventive actions will be taken at this time.If additional information is received the investigation will resume as needed.This complaint will be used for trending purposes.
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Search Alerts/Recalls
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