Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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The review of the complaint history database, revealed no trends for the lot number 8911274.The product reference (b)(4) lot number 8911274 has been manufactured for (b)(4) pieces in december 2022.The expiry date is december 2027.This product was made with the intermediate (b)(4) "im-folysil tiem im 5/15ml " lot number 8546589.This intermediate (b)(4) as been manufactured for 1861 pieces in november 2022.Checking the quality database revealed no anomaly in relation with the described product.A similar case study was done, same item number defect : drainage issue over last four years: no similary case was found.On 24th march we received, one used sample.After disinfection with anioxide 1000 catheter was tested: - inflation and deflation functionality is conformed - drainage functionality was tested: no drainage occured.A guidewire were passed inside catheter to define were it's blocked.Junction between distal tip and catheter tube was obstructed.The clinical assesment concluded: folysil catheter must only be used by trained and experienced professionals.The incident described as ¿catheter does not drain¿ happening few hours after traumatic catheterization, which may be due to a product defect (drainage lumen blocked), with clinical consequence as urinary retention may represent a clinical risk rated severity parameter level 3 related to risk of pain, urethral lesion and bleeding, urinary retention, and reintervention for change of device, referring to our clinical risk management procedure (b)(4).
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