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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR

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C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR Back to Search Results
Catalog Number 486100
Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Injury (2348); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Sample not returned.
 
Event Description
The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced constipation, mesh exposure, mesh erosion, recurrent bladder infections, 3 cm x 4 mm extrusion of mesh, extended spectrum beta-lactamases, burning, urgency, dysuria, cloudy urine, urinary frequency, cystocele, granulomatous reaction, vaginal mucosa, exhibiting mild fibrosis, inflammation of the submucosa, mesh pain, recurrent or worsening urinary incontinence, pain with intercourse, vaginal (apical) prolapse, pressure, vaginal fullness, needing to push near the anus or inside the vagina to evacuate bowel movements, slow urinary stream, trouble urinating, frequency and or urgency of urination, needing to push the bladder in to urinate, and irritation from prolapse beyond the opening of the vagina.The patient required additional surgical and non-surgical interventions.
 
Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.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 avaulta solo¿ synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, 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 vaginal wall prolapse.Urinary incontinence (stress and urge)." 1750 = "l".2348, 3274, 2993 = "nl".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR
Type of Device
AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key11096513
MDR Text Key224425008
Report Number1018233-2020-06419
Device Sequence Number1
Product Code OTP
UDI-Device Identifier00801741168024
UDI-Public(01)00801741168024
Combination Product (y/n)N
PMA/PMN Number
K082571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/01/2009
Device Catalogue Number486100
Device Lot NumberHUSA1497
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Device Age2 MO
Event Location Hospital
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received12/31/2020
Supplement Dates FDA Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK; AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight69
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