FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
MDR report key: 3131323
·
Received May 17, 2013
Report
- Report Number
- 9615742-2013-00442
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- January 9, 2006
- Report Date
- May 7, 2018
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- PMA / PMN Number
- K041176
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220250 | URETEX SUPPORT PP TRANSOBTUR2 KIT X1 | URETEX SUPPORT | OTN | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Other | PARIETEX UGYTEX PP POSTERIOR KIT X1: UGYKP, LOT #ZFJ00408, EXP: 10/31/2010, MFR DATE: 10/2005| UGYKA PARIETEX UGYTEX PP ANTERIOR KIT, X1 LOT NUMBER ZFJ00407, EXP DATE 10/31/2010, MFR DATE: 10/2005| LOT #ZFJOO407| PARIETEX UGYTEX PP ANTERIOR KIT X1: (B)(4)| PARIETEX UGYTEX PP POSTERIOR KIT X1: (B)(4)| LOT #ZFJOO408 |