(b)(4).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Narrative: directions for use, page 7, states: do not disassemble or modify the battery! one li-ion mh12210 battery was received, in a box marked "defective battery." battery had been disassembled into 6 parts and packed with the white cover which had originally protected all of the parts.The positive end showed a charred mark next to where the flat wire had been broken.
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