The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Report source: other: hc adverse incident report reference no 189915; submitted to hc (health canada) by the patient.The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an advantage mid-urethral sling device was implanted during a procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient has experienced repetitive urinary infections, difficulty restraining her urge to urinate, and constipation.Reportedly, if she uses a little laxative, her stools unnoticeably escape little by little.At night, she experiences intense pain in her left thigh and average pain in her left leg.Moreover, she reports of quite intense pain in her belly from time to time.She describes the pain in her belly as small blows of blades, tearing, and burning.Sometimes, she has intense pains all around her pelvis and she is bedridden for a few days.She has experienced intense lifting stiffness and unbearable pain when doing her natural needs.She has to spread her legs a lot; otherwise, she is standing up.Everyday, her legs are extremely swollen.In addition, she has no more sexual relations and could not event find her clitoris.Furthermore, she is still incontinent at times.
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