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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Swelling (2091); Impaired Healing (2378)
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Event Date 10/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign country: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04981, 0001822565 - 2019 - 05096, 0001822565 - 2019 - 05097.
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Event Description
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It was reported the patient underwent a full artificial joint replacement and the wound showed repeated symptoms of redness, swelling, rupture and exudation after the operation.Approximately 9 days later, the patient underwent a dilated and invasive catheter drainage, and the wound healed upon discharge.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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