MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-09-26 for TEGRESS? URETHRAL IMPLANT 653001 manufactured by C.r. Bard, Inc. (covington) -1018233.
[121855751]
The sample was not returned. The lot number is unknown; therefore, the device history record could not be reviewed. 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: "the tegress? Urethral implant clinical trial involved 374 tegress? Implant treatment injections in 174 subjects (mean follow-up of approximately 14 months). There were no deaths among study patients. The following table lists the treatment related adverse events reported during the clinical study (incidence >2%). Treatment related events are those events that were deemed to be related to either the device or the procedure. All genitourinary events were classified as treatment related. Number (%) subjects reporting treatment related adverse events event category tegress? Implant (n=174) urinary tract infection (uti) 50 (29%) delayed voiding 32 (18%) dysuria 31 (18%) exposed material 28 (16%) urinary urgency 24 (14%) urinary frequency 22 (13%) genitourinary (infection, tenderness) 20 (11%) hematuria 19 (11%) urge incontinence 16 ( 9%) worsening of incontinence (onset of urge) 14 ( 8%) outlet obstruction 13 ( 7%) pain at injection site 13 ( 7%) pelvic pain 13 ( 7%) yeast infection 12 ( 7%) leakage of urine/stress incontinence 9 ( 5%) bulking material injected into bladder 7 ( 4%) fatigue 3 ( 2%) abnormal urinalysis 3 ( 2%) bladder fullness 3 ( 2%) nocturia 3 ( 2%) pelvic heaviness 3 ( 2%) uterine fibroids 3 ( 2%) other (<2%)* 38 (n/a)* other treatment related adverse events in tegress? Urethral implant patients, occurring at frequencies of < 2%, were as follows (listed alphabetically): abdominal upset, bladder spasms, bladder stones, body aches, burning pain, cold and shivering, cyst, cystitis, feeling of decreased sensation with urination, feeling of bladder not emptying, felt faint during bulking injection, fever, garlic odor, genital pain, kidney stones, labia with erythema, lower back pain, medicinal smell to urine, nausea, partial urinary retention due to dementia, pyuria, removal of tegress? Implant, urethral burning sensation, urethral irritation, urethral redness, urethral soreness, urethral spasm, vaginal bleeding, and vulvar burning. Most treatment related adverse events occurred within 24 hours of treatment and subsequently resolved within 30 days. At the time of database closure, 92% of treatment related adverse events were resolved. The following events were persistent or resolution was unconfirmed at the time of database closure (the number of events is shown in parentheses): urge incontinence (6); leakage of urine/stress incontinence (5); worsening of incontinence (onset of urge) (5); exposed material (4); uterine fibroids (3); urinary tract infection (2); urinary frequency (2); urinary urgency (2) and one event each of genitourinary (infection/tenderness), kidney stones, nocturia, pelvic pain, urethral redness, and tegress? Implant removal. Of the treatment related adverse events, 39% were classified as mild, 58% were classified as moderate, and 3% were classified as severe. The severe treatment related adverse events included: bladder spasms, bladder stones, bulking material injected into the bladder, delayed voiding, exposed bulking material, hematuria, pelvic pain, urge incontinence, and urinary frequency. The clinical study consisted of a pilot or feasibility phase (n=28), followed by the expanded study phase (n=146). There was higher overall rate of genitourinary adverse events in the feasibility phase of the study than in the expanded phase. In particular, the rate of? Exposed material? Was higher (32% vs. 13%). This reduction in the rate of exposed material was achieved as a result of modifications to the tegress? Implant injection instructions and investigator training. During the course of the clinical investigation (both study phases), 28 subjects (16%) receiving tegress? Urethral implant treatment experienced exposed bulking material in the urethral mucosa. Patients experiencing exposed material often reported other events, particularly dysuria, delayed voiding, urinary tract infection, hematuria, urinary frequency, and urinary urgency. Exposed tegress? Implant material was associated with shallow placement and injection too proximal to the bladder neck. Over time, the urethra healed spontaneously as the mucosal surface re-epithelialized. The physician may choose to remove exposed material cystoscopically with graspers or forceps to facilitate healing. The majority of patients were injected via the transurethral approach, while a small proportion of patients were injected periurethrally. There were significantly more adverse events among tegress? Implant patients treated periurethrally; as a result, the tegress? Urethral implant instructions for use are limited to transurethral administration. Potential adverse events: although not reported in the clinical study, other potential adverse events which may occur include erosion, erythema, embolic phenomena, and vascular occlusion. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[121855752]
Na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-04445 |
| MDR Report Key | 7911492 |
| Report Source | OTHER |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-09-26 |
| 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 | TEGRESS? URETHRAL IMPLANT |
| Generic Name | TEGRESS? URETHRAL IMPLANT |
| Product Code | LNM |
| Date Received | 2018-09-26 |
| Model Number | NA |
| Catalog Number | 653001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-26 |