MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-24 for ALIGN URETHRAL SUPPORT SYSTEM BRD300RS manufactured by C.r. Bard, Inc. (covington) -1018233.
[188328675]
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: 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 overcorrection/too much tension placed on the implant. Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, 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). No sample received.
Patient Sequence No: 1, Text Type: N, H10
[188328676]
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, stress urinary incontinence, additional non-surgical and surgical intervention, a palpable sling and sutures, sling mesh erosion, vaginal erosion of midurethral sling, midline cystocele, urgency of urination, uterine prolapse, recurrent sling exposure, atrophy, poor healing, mesh contracture, interstitial cystitis, pudendal neuralgia, dyspareunia, mesh rejection, pelvic pain, trigger point injections, and placement of rectus fascia autologous sling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02042 |
| MDR Report Key | 9871192 |
| Report Source | OTHER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2012-08-07 |
| Date Added to Maude | 2020-03-24 |
| 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 | ALIGN URETHRAL SUPPORT SYSTEM |
| Generic Name | ALIGN URETHRAL SUPPORT SYSTEM |
| Product Code | OTN |
| Date Received | 2020-03-24 |
| Model Number | BRD300RS |
| Catalog Number | BRD300RS |
| Lot Number | HUWG0724 |
| Device Expiration Date | 2014-08-30 |
| 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 | 2020-03-24 |