FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 2912783
·
Received January 8, 2013
Report
- Report Number
- 2936999-2013-00020
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 12, 2012
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEA
- Product Code
- JOH
- PMA / PMN Number
- K955680
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CALLER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS REC'D, A SUMMARY OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
CUSTOMER STATED THAT THE CUFF OF THE TUBE LOOSES AIR AFTER 15 MINS OF PT USE. THE CUSTOMER STATES THE CUFF WAS INFLATED AGAIN AND AFTER THE 2ND TIME INFLATING THE TUBE WAS REMOVED AND REPLACED BY ANOTHER ONE. CALLER CONFIRMED NO NEGATIVE OUTCOME TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9028 | SHILEY | CUFFED PEDIATRIC TRACH TUBE | JOH | COVIDIEN, FORMERLY TYCOHEA | 120200656X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |