FDA Adverse Event
Other
Summary report: N
COAPTITE INJECTABLE IMPLANT
MDR report key: 2804311
·
Received October 17, 2012
Report
- Report Number
- 2135225-2012-00118
- Event Type
- Other
- Date Received
- October 17, 2012
- Date of Event
- August 11, 2009
- Report Date
- September 17, 2012
- Manufacturer
- MERZ AESTHETICS, INC
- Product Code
- LNM
- PMA / PMN Number
- P040047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS FOR LOT 1012543 WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.
Description of Event or Problem · 1
A PT ((B)(6)) WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009, THE PT WAS INJECTED WITH 2 ML COAPTITE, LOT 1012543. ON THE SAME DAY, THE PT DEVELOPED URINARY RETENTION DIAGNOSED BY PT REPORT. THE PT WAS TREATED WITH FOLEY CATHETERIZATION AND 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 | 1012543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |