FDA Adverse Event
Injury
Summary report: N
APOGEE
MDR report key: 3131157
·
Received May 22, 2013
Report
- Report Number
- MW5030279
- Event Type
- Injury
- Date Received
- May 22, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 22, 2013
- Manufacturer
- UNK
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Description of Event or Problem · 1
PT HAD PREVIOUS APOGEE AND PERIGEE MESH. DEVELOPED RECURRENT PROLAPSE AND VAGINAL PAIN AND DESIRED SURGICAL REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226520 | APOGEE | MESH | FTL | UNK | UNK | ||
| 226521 | PERIGEE | MESH | FTL | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |