MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-04 for ALYTE Y-MESH GRAFT Y100 manufactured by C.r. Bard, Inc. (covington) -1018233.
[187847620]
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: "adverse events complications associated with the proper implantation of the alyte? Y-mesh graft 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)". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187847621]
The patient's attorney alleged a deficiency against the device. Per additional information received, the patient has experienced recurrent vaginitis, vulvovaginitis, candidiasis, vaginal vault prolapse, continued pessary use, urinary tract infection, bacterial vaginosis, frequency, urgency, pelvic pain, abdominal pain, vaginal discharge, depression, prolapsed omentum secondary to vaginal wall defect (vaginal cuff dehiscence with omentum in the vagina), omentectomy, pain and pressure with bloating in the upper abdominal area, cystocele, rectocele, apical prolapse, dehiscence of internal surgical wound, incompetence of pubocervical tissue, female proctocele, mixed incontinence, adhesions, exposure of vaginal mesh, vaginal bulging, pain and pressure in vaginal/rectal area, inability to ambulate for more than a few minutes due to weakness and discomfort, pulling sensation back of vagina/rectum, dyspareunia, exposure of prolene suture, and removal of exposed suture. She has required multiple surgical and non-surgical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01545 |
| MDR Report Key | 9788425 |
| Report Source | OTHER |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2012-02-22 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGELA ROBINSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALYTE Y-MESH GRAFT |
| Generic Name | ALYTE Y-MESH GRAFT |
| Product Code | OTO |
| Date Received | 2020-03-04 |
| Model Number | NA |
| Catalog Number | Y100 |
| Lot Number | HUVL1214 |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |