(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports: "as per recommended in ifu, the catheter shall be checked on weekly or periodic basis and the catheter shall be replaced at maximum of indwelling of 29 days and advice of the supervising physician.The materials used to produce the catheter were tested per en iso (b)(4), biological evaluation of medical devices.As reported in bev-0035/20, the catheter was reported to fulfill the requirements for their specified characteristics and performance, under the intended conditions and for its intended purpose of use.As per disclosed by the caregiver, the rashes were developed from the overflow of urine that was not drained into the collection bag.Therefore, this complaint is not confirmed as the rashes were not cause by the biocompatibility of the material or the functionality of the catheter used.".
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