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Catalog Number BRD705SI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Scar Tissue (2060); Injury (2348); Constipation (3274)
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Event Type
Injury
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Manufacturer Narrative
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The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: "complications associated with the proper implantation of the ajust® sling system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over-correction/typically too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, vagina, rectum or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." (b)(4).
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Event Description
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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced mesh exposure, postmenopausal atrophic vaginitis, separation of the incision, overactive bladder, spotting with intercourse, slower urinary stream, inability to enjoy intercourse, constipation, scar tissue and adhesions at introitus, trigger point injections, mildly tender, dyspareunia, muscle spasm and sexual dysfunction.She has required multiple non-surgical interventions.
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Search Alerts/Recalls
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