Based on the info currently available, it is unk whether the device may have caused or contributed to the event.
The physician indicated that the device may not have been used in accordance with the ifu.
Additionally, no product has been returned.
No conclusion can be drawn at this time.
Available info indicates no device will be returned and/or add'l info will be provided.
We therefore, consider this report complete to the best of our current knowledge.
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