End user reports "all the catheters in both boxes (total qty 60 catheters) have rough unpolished eyelets.He said he has used these catheters for years and have never experienced any issues with the eyelets before stating they were always very smooth eyelets going in.He said one can not tell visually tell before inserting or through the packaging but he could only feel it in his urethra "the whole way" going in and out the eyelets felt like they tore him on the inside.No bleeding.He said the pain would go away as soon as the catheter was outside of him.No medical invention sought.After he removed these, he would feel the catheters and noted with his touch that the "rough parts" were indeed by the eyelets, denies anything sticking out of them." he confirmed "he is placing the coude tip upwards properly as well stating he has cath'd for many years 5 x a day and knows the proper technique.He has been using them because that is all he had.".
|
Device 36 of 60.Common device name: catheter, urethral.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).
|