FDA Adverse Event
Injury
Summary report: N
PARIETEX UGYTEX PP ANTERIOR KIT X1
MDR report key: 1040584
·
Received May 9, 2008
Report
- Report Number
- 9615742-2008-00018
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- March 12, 2007
- Report Date
- October 5, 2018
- Manufacturer
- TREVOUX - USS
- Product Code
- FTL
- PMA / PMN Number
- K051503
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED THAT FOLLOWING ANTERIOR AND POSTERIOR REPAIR PROCEDURES IN 2007, THE DOCTOR OBSERVED A MID-URETHRAL FISTULA VIA CYSTOSCOPY AND PHYSICAL EXAM. THE PATIENT EXPERIENCED URINARY LEAKAGE (18 PADS/DAY), PELVIC PAIN, DYSPAREUNIA, AND APICAL MESH EXPOSURE. THE DATE OF ONSET OF COMPLICATIONS WAS REPORTED AS ORIGINAL MONTH. THE SIZE OF THE FISTULA WAS DESCRIBED AS 1-2 CM. THE DOCTOR HAS PLANNED EXCISION OF THE MESH, UVF REPAIR WITH MARTIUS FAT PAD GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETEX UGYTEX PP ANTERIOR KIT X1 | SURGICAL MESH | FTL | TREVOUX - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |