FDA Adverse Event
Other
Summary report: N
COAPTITE INJECTABLE IMPLANT
MDR report key: 3429669
·
Received October 17, 2013
Report
- Report Number
- 2135225-2013-00114
- Event Type
- Other
- Date Received
- October 17, 2013
- Date of Event
- January 24, 2013
- Report Date
- September 20, 2013
- Manufacturer
- MERZ NORTH AMERICA, INC.
- Product Code
- LNM
- PMA / PMN Number
- P040047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ON (B)(6) 2013 THE UTI RESOLVED. PER THE PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES.
Description of Event or Problem · 1
A PT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2012 THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE, LOT 1031985. ON (B)(6) 2013 THE PT REPORTED A URINARY TRACT INFECTION (UTI). ON (B)(6) 2013 THE PT WAS PRESCRIBED MACRODANTIN 100 MG # 10.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 533604 | COAPTITE INJECTABLE IMPLANT | INJECTABLE IMPLANT | LNM | MERZ NORTH AMERICA, INC. | 1031985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |