FDA Adverse Event
Injury
Summary report: N
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
MDR report key: 2913631
·
Received November 21, 2012
Report
- Report Number
- 9615742-2012-00593
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- July 10, 2006
- Report Date
- April 27, 2018
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- 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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT NUMBER: (B)(4) FOR A "URETEX". ADD'L INFO FROM IMPORTER REPORT: PT IDENTIFIER: (B)(6), DATE OF THIS REPORT: (B)(6) 2012, BRAND NAME: URETEX TO2 URETHRAL SUPPORT SYSTEM, CAT #: 485054. (B)(6).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L INFO FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR#: 1018233-2012-01763.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URETEX SUPPORT PP TRANSOBTUR2 KIT X1 | URETEX SUPPORT | FTL | SOFRADIM PRODUCTION | NA | SFF00169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention| O | PELVISOFT ACELLULAR COLLAGEN BIOMESH| PELVISOFT ACELLULAR COLLAGEN BIOMESH |