MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-23 for ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM WITH HALO NEEDLE BRD500HL manufactured by C.r. Bard, Inc. (covington) -1018233.
[188635637]
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 align? To urethral support system may include, but are not limited to:postoperative hematoma, which may occur following the implant procedure, temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much, tension placed on the mesh sling implant, perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage,transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant. (b)(4). No sample received.
Patient Sequence No: 1, Text Type: N, H10
[188635638]
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment. Product was used for therapeutic treatment. Per additional information received, the patient has experienced leakage, lower back pain, voiding problems, dyspareunia, menopause (age (b)(6)), cancer, bladder infections, pain during intercourse, urinary incontinence, erosion, urinary tract infection, bladder outlet obstruction, dyspareunia, leakage, voiding problems, discomfort, urinary retention, vaginal/bladder infections, bacterial vaginosis, yeast (fungal) infections, vaginal pain, pelvic aching, incontinence, pelvic/perineal pain, micturition, poor urinary stream/urinary flow restriction, unspecified bladder disorder, foreign body in patient, blood loss, urinary cystitis, urinary frequency, fibrosis, adhesions, bladder trabeculation, scar tissue/scarring, urethral injury, elevated blood pressure, voiding dysfunction, depression, anxiety, dizziness, cystitis, headache, fatigue, malaise, urinary discomfort, night sweating, sleep disturbances, candidiasis, backache, blood in urine (hematuria), nonsurgical and additional surgical intervention,bladder outlet obstruction, recurrent urinary tract infections, urinary retention, vaginal pain, restriction of urinary flow and dyspareunia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02005 |
| MDR Report Key | 9865802 |
| Report Source | OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2009-09-29 |
| Date Added to Maude | 2020-03-23 |
| 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 TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM WITH HALO NEEDLE |
| Generic Name | ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM WITH HALO NEEDLE |
| Product Code | OTN |
| Date Received | 2020-03-23 |
| Model Number | BRD500HL |
| Catalog Number | BRD500HL |
| Lot Number | HUTH2008 |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 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 | 2020-03-23 |