MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-19 for AJUST? ADJUSTABLE SINGLE-INCISION SLING BRD705SI manufactured by C.r. Bard, Inc. (covington) -1018233.
[188635296]
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 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/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). Sample not received.
Patient Sequence No: 1, Text Type: N, H10
[188635297]
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, injury, disability and impairment. Per additional information received, the patient has experienced mixed incontinence urge and stress, urinary frequency, urinary leakage requiring wearing two maxi pads per day, nocturia, palpable band under urethra that was tight and uncomfortable, vaginal bulge (prolapse), nervousness, depression, anxiousness, detrusor overactivity, bladder outlet obstruction, sexual problems, pelvic pain, weak stream, incomplete emptying, nausea, abdominal pain, diarrhea, constipation, stool incontinence, back pain, easy bruising, curled and twisted sling distally, nerve related pain radiating from her vaginal area down to her leg associated with sudden leakage, obstruction from suburethral sling, grade one to two cystocele with scar tissue in the mid to distal urethral level, abnormal vaginal bleeding, low sexual desire, mild scoliosis and a very narrow distal urethra with proximal ballooning per voiding cystourethrogram, fatigue, anxiety, painful urination, and a urinary tract infection. She has required multiple nonsurgical interventions and one surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01141 |
| MDR Report Key | 9727941 |
| Report Source | OTHER |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2011-05-27 |
| Date Added to Maude | 2020-02-19 |
| 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 | AJUST? ADJUSTABLE SINGLE-INCISION SLING |
| Generic Name | AJUST? ADJUSTABLE SINGLE-INCISION SLING |
| Product Code | PAH |
| Date Received | 2020-02-19 |
| Catalog Number | BRD705SI |
| Lot Number | HUVE1641 |
| Device Expiration Date | 2013-05-31 |
| 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 | 2020-02-19 |