H10: the device for this malfunction has not been returned to the manufacturer for evaluation, however, medical records and an x-ray image have been provided.The investigation is confirmed for the alleged positioning issue, however, it is inconclusive for the alleged migration.Based upon the available information, the definitive root cause is unknown.The device was labeled for single use.H10: g4 h11: b5, h6 (results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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