FDA Adverse Event
Injury
Summary report: N
FLEX-SEAL FMS
MDR report key: 1003529
·
Received February 26, 2008
Report
- Report Number
- 2243969-2008-00003
- Event Type
- Injury
- Date Received
- February 26, 2008
- Date of Event
- January 28, 2008
- Report Date
- January 28, 2008
- Manufacturer
- CONVATEC
- Product Code
- KNT
- PMA / PMN Number
- K032734
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTED BY THE COMPLAINANT AS FOLLOWS: THE PATIENT WAS A MALE, DOCTOR DID NOT REMEMBER THE INSERTION DATE, BUT CLOSE TO 29 DAYS AFTER INSERTION, THE PATIENT HAD A GI BLEED WHICH REQUIRED A BLOOD TRANSFUSION. THE FMS PRODUCT WAS REMOVED AND A SCOPE WAS PERFORMED. AN ERODED ULCER WITH A BLEEDING VESSEL WAS NOTED EXACTLY WHERE THE FLEXI-SEAL BALLOON WOULD HAVE SAT IN THE RECTUM. THIS PATIENT HAD NO HISTORY OF A GI BLEED PRIOR TO THIS INCIDENT. NO FURTHER INFORMATION WAS PROVIDED. REPORTED TO THE FDA ON FEBRUARY 26, 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEX-SEAL FMS | FECAL MANAGEMENT SYSTEM | KNT | CONVATEC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |