(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
|
It was reported that a patient underwent a sling procedure on (b)(6) 2014 and mesh was implanted.The patient reported not knowing the pain and immune/allergy responses were due to the medical device.The patient had mon pubis pulling and pain, pain in lower back, right thigh and leg within months of the initial surgery.The patient further reported experiencing unexplained rashes, psoriasis, hair loss, continual thrush, regular urinary tract infection symptoms, continence issues, brain fog and memory issues.The patient also experienced bleeding in (b)(6) 2016 and vaginal erosion was found.A revision was performed on (b)(6) 2018.The patient contracted staph and was given 7 days of in hospital iv antibiotics & a further 6 weeks of oral antibiotics.The implant was tested and returned a positive finding of candida and staph.The patient saw their general physician on a regular basis, had ultrasounds to find cause of pubic pain, had acupuncture, was put on opioids to manage pain, took medication for overactive bladder, permanent candida die off medication, was sent to counselling with a psychologist and prescribed antidepressants.The patient now needs continence products and has bladder and vaginal prolapse.No further information is available as reporter details have not been disclosed (confidential).
|