MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-11-21 for TEGRESS? URETHRAL IMPLANT 653001 manufactured by C.r. Bard, Inc. (covington) -1018233.
[92719372]
Investigation is still in progress, once the investigation is complete a supplemental will be filed. 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. Sample not returned.
Patient Sequence No: 1, Text Type: N, H10
[92719373]
It was reported in the patient? S medical records that as a result of having the product implanted, the patient has experienced urinary stress and urge incontinence, pain, unspecified urinary problems, blood loss, hematuria, cystocele and rectocele (prolapse), urgency, dysuria, abdominal pain, flank pain, dyspareunia, atrophic vaginitis, narrow vaginal vault, tenderness, leukocytes in urine, bladder trabeculations, cyst, bladder neck hypermobility, vaginal bleeding, obstruction, headache, urinary frequency, scar tissue, high pressure voiding, injection material extravasation and required nonsurgical and additional surgical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-06034 |
| MDR Report Key | 7050998 |
| Report Source | OTHER |
| Date Received | 2017-11-21 |
| Date of Report | 2017-12-06 |
| Date Mfgr Received | 2017-11-21 |
| Device Manufacturer Date | 2005-02-28 |
| Date Added to Maude | 2017-11-21 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 2017-11-21 |
| Model Number | NA |
| Catalog Number | 653001 |
| Lot Number | 0502A071 |
| Device Expiration Date | 2008-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 13 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 | 2017-11-21 |