Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.A product unit was received for evaluation.Unit returned was received inside of a plastic bag.During visual inspection, it was noticed that the unit was damaged.During functional testing, the unit was submitted to leak testing per the procedure using an equipment manometer and the unit presented leakage.The complaint was confirmed.An escalation was performed for leakage failure to investigate and determine the root cause.All corrective actions will be addressed and implemented through a non-conformance.Additional information: d3, d4 (udi), g2, g5 are unknown., corrected data: d1.
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