FDA Adverse Event
Malfunction
Summary report: N
EASICATH CH12 MALE
MDR report key: 2000892
·
Received February 24, 2011
Report
- Report Number
- 3006606901-2011-00002
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Report Date
- January 27, 2011
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K973070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS RETURNED AND EVALUATED. VISUAL EXAMINATION AND FRICTION TESTING WAS PERFORMED AND NO SHARP EDGES ON THE CATHETER WERE FOUND. BASED UPON THE DEVICE EVALUATION, THIS COMPLAINT CANNOT BE CONFIRMED AS REPORTED.
Description of Event or Problem · 1
PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(4) 2011. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A CATHETER WITH SHARP/ROUGH EYELETS. IT WAS REPORTED THERE WAS A SHARP EDGE ON THE EYE NEAREST THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASICATH CH12 MALE | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 0535201028 | 2612743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |