FDA Adverse Event
Injury
Summary report: N
COAPTITE INJECTABLE IMPLANT
MDR report key: 1317602
·
Received February 18, 2009
Report
- Report Number
- 2135225-2009-00003
- Event Type
- Injury
- Date Received
- February 18, 2009
- Date of Event
- January 16, 2009
- Report Date
- January 20, 2009
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN PLANS TO USE FURTHER MEDICAL INTERVENTION TO INCISE THE LOBE AND RELEASE THE COAPTITE, ELIMINATING THE BLOCKAGE.
Description of Event or Problem · 1
PATIENT WAS INJECTED WITH COAPTITE IN 2008. DURING POST-PROCEDURE FOLLOW-UP, IT WAS LEARNED THE PATIENT WAS EXPERIENCING URINARY TRACT INFECTIONS. THE PHYSICIAN PERFORMED A CYSTOSCOPY REVEALING A BULGE OF COAPTITE IN THE BLADDER WALL NEAR THE BLADDER NECK, OBSTRUCTING THE URETHRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAPTITE INJECTABLE IMPLANT | INJECTABLE IMPLANT | LNM | BIOFORM MEDICAL, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |