Lot Number 1960465 |
Device Problems
Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
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Event Date 09/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.The following mdrs were submitted: 3013450937-2023-00230, 3013450937-2023-00231, 3013450937-2023-00232, 3013450937-2023-00233, 3013450937-2023-00234, 3013450937-2023-00235, 3013450937-2023-00236, 3013450937-2023-00237.
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Event Description
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This patient originally received a dfr on (b)(6) 2023 and he presented with symptoms of possible infection.The doctor decided to bring the patient back for a full washout and poly exchange.This was the first washout/exchange.
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Manufacturer Narrative
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Ultimately, the root cause of the patient's infection was unable to be determined.Based upon the device history records, sterilization records, and interview with the sales representative the investigation concluded that the root causes of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.The following mdrs were submitted together as part of this complaint and investigation: 3013450937-2023-00229, 3013450937-2023-00243, 3013450937-2023-00244, 3013450937-2023-00245, 3013450937-2023-00246, 3013450937-2023-00247, 3013450937-2023-00248, 3013450937-2023-00249, 3013450937-2023-00251.
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Search Alerts/Recalls
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