FDA Adverse Event
Injury
Summary report: N
COAPTITE
MDR report key: 867243
·
Received June 16, 2007
Report
- Report Number
- 2135225-2007-00006
- Event Type
- Injury
- Date Received
- June 16, 2007
- Date of Event
- May 29, 2007
- Report Date
- June 12, 2007
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DR. INFORMED THE BOSTON SCIENTIFIC SALES REP THAT, THE PT IS NO LONGER IN URINARY RETENTION. THE PT'S SYMPTOMS HAD RESOLVED WITHIN 48 HOURS OF INSERTION OF THE CATHETER. THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CORP INFORMED BIOFORM MEDICAL ABOUT A PHYSICIAN WHO REPORTED A PT THAT WENT TO THE EMERGENCY ROOM, APPROX ONE WEEK AFTER THE COAPTITE BULKING PROCEDURE. THE PT WAS FOUND TO BE IN URINARY RETENTION AND A FOLEY CATHETER WAS INSERTED INTO THE BLADDER. THE PT WAS RELEASED FROM THE ER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAPTITE | INJECTABLE IMPLANT | LNM | BIOFORM MEDICAL, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |