(b)(4).Batch #unk.Investigation summary: a photo image along with the device was returned.Upon visual inspection of one photo, the following was observed: the photo shows a package from top view and damage can be seen on the corner of the blister.The analysis results found that a harh36 device was returned outside its original package and no packaging was returned for analysis.Due to the condition of no packaging returned for analysis, no visual inspection could be performed to evaluate the incident reported.It could not be determined what may have cause the reported event.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.The event could not be confirmed, as no packaging was returned for analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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