ALIGN TO URETHRAL SUPPORT SYSTEM
Report
- Report Number
- 1018233-2012-01957
- Event Type
- Injury
- Date Received
- December 6, 2012
- Report Date
- November 7, 2012
- Manufacturer
- BARD SHANNON LTD
- Product Code
- FTL
- PMA / PMN Number
- K070073
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
Narratives
THE DEVICE REMAINS IMPLANTED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2012-01956 AND 01958.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALIGN TO URETHRAL SUPPORT SYSTEM | FTL | BARD SHANNON LTD | NA | HUTC2270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PELVISOFT ACELLULAR COLLAGEN BIOMESH| URETEX URETHRAL SUPPORT SYSTEM |