This case was reviewed and investigated according to the manufacture¿s policy.A2-a5: no patient involvement.B6 & b7: no patient involvement.C: not applicable.D4: expiration date is not applicable.D6, d7, & d10: not applicable; no patient involvement.H6: based on the returned screen, the probable cause is likely damaged from use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.H7 & h9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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