Model Number N/A |
Device Problems
Failure to Cut (2587); Calibration Problem (2890); Material Twisted/Bent (2981); Naturally Worn (2988); Patient Device Interaction Problem (4001)
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Patient Problem
Laceration(s) (1946)
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Event Type
Injury
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Event Description
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It was reported that during surgery the skin graft did not harvest properly using a three-inch guard resulting in a poor-quality skin graft.The taken graft was damaged as the central piece of skin was missing in the graft, leaving only two small strips.An additional graft was taken which led to a larger donor site wound on the patient's thigh.There was no delay noted in the procedure.It was also reported that all of the hospitals' dermatome kits are old and none of them have been serviced/maintained.Due diligence is complete and there is no additional information available.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 : (b)(6).G2 country: united kingdom.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01170-1.
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Manufacturer Narrative
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This mdr is a duplicate of 0001526350-2023-01153.The initial report was created in error and should be voided.
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Event Description
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This mdr is a duplicate of 0001526350-2023-01153.The initial report was created in error and should be voided.
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Search Alerts/Recalls
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