FDA Adverse Event
Other
Summary report: N
COAPTITE INJECTABLE IMPLANT
MDR report key: 2334518
·
Received November 4, 2011
Report
- Report Number
- 2135225-2011-00113
- Event Type
- Other
- Date Received
- November 4, 2011
- Report Date
- October 7, 2011
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LNM
- PMA / PMN Number
- P040047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT#: 1010736, EXPIRATION DATE: 09/01/2011. THE DEVICE HISTORY RECORDS FOR LOT 1010558, 1010736 WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.
Description of Event or Problem · 1
A PATIENT (B)(6) WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 1.0 ML COAPTITE ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT EXPERIENCED URINARY RETENTION DIAGNOSED BY BLADDER ULTRASOUND. THE PATIENT WAS TREATED WITH STRAIGHT AND FOLEY CATHETERIZATION. THE PATIENT RECOVERED ON (B)(6) 2009. PER PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND DEFINITELY RELATED TO COAPTITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAPTITE INJECTABLE IMPLANT | INJECTABLE IMPLANT | LNM | MERZ AESTHETICS, INC. | 1010558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |