(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted, along with obtaining the sterilization certificate.Results: as a device analysis cannot determine the root cause of the post-operative infection, no device testing methods are available.Conclusions: as the device analysis cannot determine the root cause of the post-operative infection, we are unable to determine the cause of the reported event.Post-operative infection can be due to multiple variables.Patient factors, healthcare provider factors, technique factors, medical device/product factors, equipment factors and environmental factors are a few variables to consider.Further information has been requested, however, not provided.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Should additional information pertinent to this case be received, a follow up report will be submitted.
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Procedure: c-section.Cathplace: asku.Please reference: 2026095-2015-00347/15-01088(b), 2026095-2015-00348/15-01087(a) and 2026095-2015-00349/15-01087(b).Report #1 of #2, patient 1: it was reported by the sales rep that two incidents of infection occurred with (b)(6) hospital within the last 6 weeks.Patient #1: the patient had a c-section.The patient developed a seroma and had to return to the operating room for treatment and was prescribed antibiotics for 2 weeks.No further information was provided.The device will not be returning for evaluation.
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