FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
MDR report key: 3093894
·
Received April 24, 2013
Report
- Report Number
- 9615742-2013-00318
- Event Type
- Injury
- Date Received
- April 24, 2013
- Date of Event
- November 8, 2006
- Report Date
- June 4, 2018
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- PMA / PMN Number
- K041176
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
MEDTRONIC COMPLAINT REPORT: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Description of Event or Problem · 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. REASON FOR MESH IMPLANTATION: RECURRENT URINARY STRESS INCONTINENCE PROCEDURE (S) PERFORMED: URETEX TRANSOBTURATOR SLING COMPLICATIONS POST IMPLANT: PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176642 | URETEX SUPPORT PP TRANSOBTUR2 KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other |