FDA Adverse Event
Injury
Summary report: N
PERIGEE
MDR report key: 2880920
·
Received December 13, 2012
Report
- Report Number
- 2183959-2012-03194
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- November 1, 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
LAWYER-FILED REPORT - (B)(4). SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
RELATED TO MFR REPORT # 2183959-2012-03192, 03193. IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A PERIGEE PROLAPSE REPAIR SYSTEM ON OR ABOUT (B)(6) 2008, TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, SEVERE EMOTIONAL DISTRESS, ANGUISH, ANXIETY, PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, IRREPARABLE BODILY INJURY, HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERIGEE | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R| S | ELEVATE PROLAPSE REPAIR SYSTEM| MINIARC SLING SYSTEM| MINIARC SLING SYSTEM| ELEVATE PROLAPSE REPAIR SYSTEM |