FDA Adverse Event
Malfunction
Summary report: N
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
MDR report key: 4242323
·
Received November 11, 2014
Report
- Report Number
- 9615742-2014-00335
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- February 21, 2007
- Report Date
- October 29, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K041176
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BARD¿S TRACKING NUMBER: (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. MEDICAL HISTORY: GENUINE STRESS INCONTINCE AND URETHRAL HYPERMOBILITY.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MENORRHAGIA, INCREASING SIZE OF FIBROIDS, VAGINAL MESH EXPOSURE, EROSION, INCREASED PELVIC PAIN, CAN FEEL MESH, FULLNESS SUPRAPUBICALLY, BOWEL INJURY/INADVERTENT ENTEROTOMY (BOWEL PERFORATION), BLOOD LOSS, RETENTION OF UTERINE FRAGMENTS (FOREIGN BODY), AND REQUIRED ADDITIONAL SURGICAL AND NONSURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727565 | URETEX SUPPORT PP TRANSOBTUR2 KIT X1 | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | SOFRADIM PRODUCTION | URETEXTO2 | SGJ00513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |