FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP KIT X1
MDR report key: 3421311
·
Received October 10, 2013
Report
- Report Number
- 9615742-2013-01969
- Event Type
- Injury
- Date Received
- October 10, 2013
- Date of Event
- April 26, 2006
- Report Date
- September 26, 2013
- 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
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, BLOOD LOSS, WHITE AND RED BLOOD CELLS/MUCOUS/BACTERIA IN URINE, ESCHERICHIA COLI (BACTERIAL INFECTION), ELEVATED WHITE BLOOD CELLS, INCREASED RED BLOOD CELL/HEMOGLOBIN/HEMATOCRIT LEVELS, KELBSIELLA PNEUMONIAE AND NON-SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518269 | URETEX SUPPORT PP KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION | SGA00160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |