Model Number 72404280 |
Device Problems
Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2019 |
Event Type
malfunction
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Event Description
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It was reported that the inflatable penile prosthesis cylinders and pump were in a package with inhibizone sticker on the outside.This product was non-inhibizone inflatable penile prosthesis cylinders and pump.Another of the same device was used to complete the surgery.
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Manufacturer Narrative
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Incorrect labeling was reported.The device was not returned with the outer packaging that included the alleged incorrect inhibizone labeling.The ams700 device was visually inspected and functionally tested.No leak was found.The cylinders performed within specifications.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The deflation test results were out of specification, it took greater than 14 seconds to deflate from 20 psi to 4 psi.The specification is 14 seconds or less.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Product analysis could not confirm the reported labeling allegation; however allegations were concerned through (b)(4).The product record review indicated that the product met all in-process specifications prior to leaving bsc and the reported events do not represent a new or unanticipated event.The investigation conclusion code of quality control deficiency was chosen because the referenced (b)(4) confirms the allegation against the labeling.Based on the results of this investigation, this event is escalated to (b)(4).
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Event Description
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It was reported that the inflatable penile prosthesis cylinders and pump were in a package with inhibizone sticker on the outside.This product was non-inhibizone inflatable penile prosthesis cylinders and pump.Another of the same device was used to complete the surgery.
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Search Alerts/Recalls
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