FDA Adverse Event
Malfunction
Summary report: N
URINARY CATHETER - NELATON UST. 16/040CM/78 0C
MDR report key: 3032959
·
Received April 1, 2013
Report
- Report Number
- 3005778470-2013-00017
- Event Type
- Malfunction
- Date Received
- April 1, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 7, 2013
- Manufacturer
- CONVATEC
- Product Code
- KOD
- PMA / PMN Number
- K896729
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON AVAILABLE INFORMATION, MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS. A ROUGH OR JAGGED EDGED CATHETER MAY INJURE THE SOFT TISSUES OF THE URETHRA IN THE PROCESS OF INSERTION OR REMOVAL. THIS MAY RESULT IN BLEEDING WITH HEALING BY SCARRING. A 3 CLAIMED SAMPLES HAVE BEEN RECEIVED AND EVALUATED. THE SAMPLES DID NOT MEET SPECIFICATION. THERE IS A FIN ON THE CATHETER TIP END. REPORTED TO THE FDA ON (B)(4) 2013.
Description of Event or Problem · 1
COMPLAINT RECEIVED AS FOLLOWS: "IS CUSTOMER: DENTSPLY MOULDING FIN ON THE END OF CATHETER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133322 | URINARY CATHETER - NELATON UST. 16/040CM/78 0C | CATHETER, UROLOGICAL | KOD | CONVATEC | 01241620 | 458773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |