FDA Adverse Event
Injury
Summary report: N
AMS PERIGEE SYSTEM
MDR report key: 3852123
·
Received June 5, 2014
Report
- Report Number
- 2183959-2014-00198
- Event Type
- Injury
- Date Received
- June 5, 2014
- Report Date
- May 8, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT DATE: (B)(6) 2009.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED VAGINAL PAIN AND POST COITAL BLEEDING. THE REVISION SURGERY WAS ON (B)(6) 2009 THAT INCLUDED 1 CM TRIM OF MESH EROSION, MOBILIZATION OF EDGES AND RE-EPITHELIALIZATION.
Description of Event or Problem · 1
RELATED TO MFR REPORT NO.: 2183959-2014-00196, 2183959-2014-00197, 2183959-2014-00199, 2183959-2014-00200. IT WAS REPORTED THE PATIENT HAD HER PERIGEE GRAFT REVISED IN (B)(6) 2009. IT WAS FURTHER NOTED THE PATIENT WAS USING ESTROGEN CREME. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329476 | AMS PERIGEE SYSTEM | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |