FDA Adverse Event
Injury
Summary report: N
AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
MDR report key: 3994140
·
Received August 8, 2014
Report
- Report Number
- 2183959-2014-00351
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- September 10, 2013
- Report Date
- July 9, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RELATED TO MANUFACTURER REPORT # 2183959-2014-00350. IT WAS REPORTED THE PATIENT HAD AN APOGEE SLING IMPLANTED. IT WAS REPORTED THE PATIENT HAD A MEDICAL HISTORY OR "DEPRESSIVE SYNDROME" AND DYSLIPIDEMIA. IT WAS INDICATED THAT AFTER THE APOGEE WAS IMPLANTED, THE PATIENT EXPERIENCED "VAGINAL BLEEDING, HEMATURIA, AND DYSURIA" WHICH WAS NOT RELATED TO THE DEVICE. "URGENCY DE NOVO" WAS ALSO REPORTED. IT WAS INDICATED THAT THE EVENT WAS RESOLVED ON (B)(6) 2013. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468758 | AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | ELEVATE ANTERIOR AND APICAL SLING IMPLANT |