FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3902273
·
Received June 25, 2014
Report
- Report Number
- 9615742-2014-00219
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- April 30, 2009
- Report Date
- June 11, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K012949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4). INITIAL REPORT SENT TO FDA ON 06/25/2014.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UROGYNECOLOGY. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.
Description of Event or Problem · 1
PER OPERATIVE FINDINGS, THE PATIENT EXPERIENCED PAIN, PROLAPSE, RECTOCELE, FEELING OF GRAFT MATERIAL IN THE VAGINA, EROSION, DYSPAREUNIA, URGENCY, URINARY FREQUENCY, VAGINAL DRYNESS, LOW GRADE TEMPERATURE, SINUS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370065 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |