This follow up mdr is created to document the conclusion of the investigation.After receiving this complaint, we searched for other complaint and we found another complaint on this lot number (6710492) but for a different issue.3 similar cases were found for ab6a22 since ce marking, with a deflation difficult issue unfortunately no sample is available from the customer and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.It is concluded that the risks identified are still acceptable and considered as safe.Our clinical concluded : urethral catheterization with balloon catheters (foley or prostatic catheters) is a routinely clinical practice and incidents of difficulty or impossibility to remove catheters are quite common.This type of medical device must only be used by trained and experienced professionals.The choice of the size, balloon volume and material of catheter is under the responsibility of the healthcare professional based on the patient status and planned indwelling time.Managing a retained or non-deflating balloon catheter is a common activity learned during nursing training, but in case of unsuccessful attempts, urologist should solve the issue.Forceful removal of a non-deflated balloon catheter should be avoided.This may cause clinical conséquences such as injury to the urethra or men's prostate with possible urethrorrhagia and pain for the patients.In major cases, there is no risk for the patient, or limited medical risk for the patient despite medical intervention.
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