FDA Adverse Event
Injury
Summary report: N
ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR
MDR report key: 3022762
·
Received March 22, 2013
Report
- Report Number
- 2183959-2013-00761
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH AN ELEVATE ANTERIOR TO TREAT BLADDER PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD PAIN ON RIGHT SIDE AT SSL FIXATION AND MESH EXPOSURE IN MIDLINE FROM HEMATOMA AFTER INITIAL IMPLANT. THE GRANULATION TISSUE AT MIDLINE WAS REMOVED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119090 | ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |