FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0MM VOCALAID TRACHEOSTOMY TUBE
MDR report key: 2030339
·
Received March 21, 2011
Report
- Report Number
- 2183502-2011-00090
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- January 31, 2011
- Report Date
- March 15, 2011
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 2 WEEKS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX 8.0MM VOCALAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | JOH | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 1819414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |