Manufacturing review: the dhr review was not performed for this investigation as no lot number has been provided.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged reaction post port implant issue due to the fact that no sample was returned for evaluation.Although a definitive root cause could not be determined, the following contributing factor depth placement too shallow could have potentially caused or contributed to the reported event.
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