Integra has completed their internal investigation on 10/23/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: a review of batch history record indicates that lot met the requirements before released to finished goods.Lot info.: lot no.305000301322, mfg date: 25 aug 2014 and exp.Date: 31 aug 2017 complaint history, model 110-4xxx, from aug-2012 through aug-2015 reviewed; there was no other complaint that issued with complaint code.Conclusion: the reported customer complaint that the ¿the outer package in broken, but the package inside is unbroken¿ was verified.The returned product was examined and the product carton appeared to be damaged.It is important to note that the sterile barrier was not damaged or affected by the product carton damage.The root cause of this issue can be attributed to shipping or storage conditions.
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