Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.The lot history record (lhr) could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the reported information, a definitive cause for the packaging damage could not be determined.It may be possible that the damage occurred at the account and the product pouch was inadvertently placed back on the shelf; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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