FDA Adverse Event
Injury
Summary report: N
FLEXI-SEAL FMS
MDR report key: 1802555
·
Received August 10, 2010
Report
- Report Number
- 2243969-2010-00035
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 19, 2010
- Manufacturer
- CONVATEC
- Product Code
- KNT
- PMA / PMN Number
- K032734
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
REPORTED BY THE COMPLAINANT AS FOLLOWS: THREE PATIENTS HAD RECTAL BLEEDINGS WHILE USING FLEXI-SEAL (NOT: SIGNAL) AT THE BEGINNING OF 2010. ACCORDING TO THE DOCTOR, CAUSALITY IS POSSIBLE BUT NOT PROVEN. BECAUSE OF THESE BLEEDINGS ALL THESE PATIENTS HAD TO BE REFERRED TO THE (B)(6) HOSPITAL IN (B)(6) WHERE AT LEAST IN ONE CASE A PRESSURE ULCER WAS SEEN. IN THE MEANTIME ONE OF THESE PTS' DIED AS A RESULT OF A DIFFERENT DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXI-SEAL FMS | FECAL MANAGEMENT SYSTEM | KNT | CONVATEC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |