MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-28 for ALYTE Y-MESH GRAFT Y500 manufactured by C.r. Bard, Inc. (covington) -1018233.
[188330791]
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 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). No sample received.
Patient Sequence No: 1, Text Type: N, H10
[188330792]
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability, impairment per additional information received the patient experienced periurethral pain, dyspareunia, apical vaginal pain, levator myalgia, frequency of urination, stress urinary incontinence, right and left lower abdominal pain, cystocele, laparoscopic adhesiolysis, sling removal, mesh removal, paravaginal repair, laparoscopic burch procedure, suprapubic pelvic pain, urine leakage, intrinsic sphincter dysfunction, stricture and atresia of vagina, urgency of urination, nocturia, feeling of incomplete bladder emptying, generalized intra-abdominal and pelvic swelling, mass and lump, right upper and lower quadrant pain, abdominal distention, urge incontinence, kidney infection, shortened vagina, severe pain at the apex, perineal abscess, retroperineal fibrosis on the left pelvic sidewall, left ureterolysis, adhesions, placement of ureteral stent, large amount of fibrosis and adhesive tissue at left ovary, pelvic scar tissue with removal, laparoscopic neovagina, left ovary removal, perineal body mass removal, hematoma, urinary tract infection, urinary retention, constipation, urethral kink, poor urinary stream, straining to void, low back pain, recurrent vaginal vault prolapse, anterior vaginal wall prolapse, sacral colpopexy with insertion of fortiva dermal graft, required multiple non surgical and surgical interventions, recurrent yeast infections, itching and discharge, vaginitis, pelvic pain, severe abdominal distention/bloating, anxiety and depression,bilateral obturator muscle myalgia, frequency, husband being stabbed with a wire suture during intercourse, extensive adhesions, incontinence without sensory awareness, placement of single incision altis sling, hematuria, overactive bladder, urethral inflammation with severe pain, rotational descent of the apex and bladder, bladder distention and spasms, spraying of urine, pelvic relaxation, bladder descensus, left ovary hemorrhagic cyst, perineal pain, unsuccessful bladder instillations and rescues, dysuria, pressure, feeling like a corn cob was in her rectum, recurrent urinary tract infections, cystitis, unable to hold bladder, myalgia, possible bacterial vaginitis, mixed urinary incontinence, sling revision, urethral lysis, retropubic mesh tape sling placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01430 |
| MDR Report Key | 9770161 |
| Report Source | OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2013-04-05 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Model Number | Y500 |
| Catalog Number | Y500 |
| Lot Number | HUXB0334 |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 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 | 2020-02-28 |