SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 72200147 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 02/26/2019 |
Event Type
Injury
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Event Description
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It was reported that after a procedure, a pain, swelling and micro bloody exudation in the operation area.Is unknown if a delay happened in the procedure, and if a backup device was available.
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Event Description
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It was reported that after a knee procedure, patient experienced a pain, swelling and micro bloody exudation in the operation area.It is unknown if there was surgical delay or if a backup device was available to complete the procedure.Patient was reported to be in good condition.
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Manufacturer Narrative
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One 20mm ultra cl endobutton used for treatment, was not returned for evaluation.Due to product unavailability, physical evaluation, full investigation and conclusions were limited.There was no relationship confirmed between the reported event and the device.There is no objective evidence to suggest a direct link between the symptoms and product used during the procedure.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use which includes recommendations, precautionary statements and instructions for proper use of product.If objective evidence or relevant information becomes available to assist with evaluation the complaint will certainly be revisited.This was considered an isolated occurrence as there have been no other complaints affiliated with this lot.Product met specifications upon release to distribution.Complaint history review found no other similar reports.No clinically relevant documentation was provided for inclusion in a medical investigation; therefore, a thorough medical assessment could not be performed.It was communicated that the patient was discharged home in good status; however, "no more information can be provided.".
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