FDA Adverse Event
Injury
Summary report: N
PERIGEE
MDR report key: 1772166
·
Received July 23, 2010
Report
- Report Number
- 2183959-2010-00313
- Event Type
- Injury
- Date Received
- July 23, 2010
- Date of Event
- July 3, 2007
- Report Date
- July 1, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE MALFUNCTION WAS REPORTED. DEVICE WAS NOT EXPLANTED. OCCURRENCE FOR PAIN IS CONSISTENT WITH RISK MANAGEMENT DOCUMENTATION.
Description of Event or Problem · 1
POST MARKET CLINICAL PATIENT WAS IMPLANTED WITH PERIGEE ON (B)(6) 2007. ON (B)(6) 2009, PHYSICIAN REPORTED PAIN/DISCOMFORT-PERINEAL. THE PHYSICIAN DETERMINED THE EVENT WAS RELATED TO THE DEVICE AND THE PROCEDURE. THE EVENT WAS RESOLVED WITHOUT INTERVENTION ON (B)(6) 2007. ADDITIONAL INFORMATION RECEIVED ON 07/01/2010 INDICATES THE EVENT WAS CONTINUING WHEN PATIENT EXITED THE STUDY ON (B)(6) 2009. UNABLE TO OBTAIN ADDITIONAL INFORMATION. PATIENT WAS TAKING MEDICATION: PARACETAMOL 1 TO 3 PER DAY AS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERIGEE | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. | 72404046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Disability | MONARC |