The customer cannot identify the exact gown worn by the resident, however it is believed that this could be the involved catalog number.The resident is no longer there, so no additional information is available.The lot number was not provided, therefore the device history record could not be reviewed.The sample was not available for evaluation.Historical trending was done for the last year, and this is the only reported incident for this product for this issue; therefore this is considered to be an isolated event.Based on the information provided and without a sample evaluation, the reported issue of strike through was unable to be confirmed.The root cause was not determined, and no corrective action taken.All finished goods are made from qualified material that is tested before use.Final finished product must meet product specification and process requirements before final release to salable inventory.We will continue to monitor complaints for issues of this nature.
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