FDA Adverse Event
Injury
Summary report: N
APOGEE SYSTEM
MDR report key: 2744712
·
Received September 11, 2012
Report
- Report Number
- 2183959-2012-02620
- Event Type
- Injury
- Date Received
- September 11, 2012
- Date of Event
- November 6, 2006
- Report Date
- August 21, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
RELATED TO MFR REPORT#: 2183959-2012-002621. WAS IMPLANTED WITH AN APOGEE MESH SYSTEM ON (B)(6) 2006, TO TREAT HER STRESS URINARY INCONTINENCE. IT WAS ALLEGED THAT FROM (B)(6) 2006 THROUGH PRESENT, THE PLAINTIFF EXPERIENCED INJURIES, INCLUDING, BUT NOT LIMITED TO CHRONIC DEBILITATING PAIN, DISCOMFORT, DYSPAREUNIA, URINARY PROBLEMS, INFECTIONS, AND WORSENING INCONTINENCE. IT WAS ADDITIONALLY ALLEGED THE PLAINTIFF REQUIRED AND WILL CONTINUE TO REQUIRE HEALTHCARE AND SERVICES, SUFFERED MENTAL ANGUISH, SEVERE AND PERMANENT INJURIES AS WELL AS OTHER SUCH DAMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APOGEE SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S | IMPLANTED:| PPERIGEE |