C.R. BARD, INC. (COVINGTON) -1018233 AJUST ADJUSTABLE SINGLE-INCISION SLING; AJUST® ADJUSTABLE SINGLE-INCISION SLING
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Catalog Number BRD705SI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Fever (1858); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Uterine Perforation (2121); Urinary Frequency (2275); Injury (2348); Disability (2371); Hematuria (2558); Dysuria (2684); 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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It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.
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Manufacturer Narrative
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1750, 2120, 1928= "l".Correction: d4.
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Event Description
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Per additional information received on (b)(6) 2021, the patient experienced mesh erosion, urinary incontinence, urinary tract infection, and required additional surgical intervention.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per additional information received, the patient experienced urinary frequency, nocturia, constipation, dysuria, fever, hematuria, urinary incontinence, erosion of implanted vaginal mesh to surrounding organ, urethral mesh perforation, urge incontinence, mesh perforation across the entire mid to proximal urethra.Urinary tract infections, bladder infections due to erosion of mesh and urgency of urination which required surgical and non-surgical interventions.
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Search Alerts/Recalls
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