FDA Adverse Event
Other
Summary report: N
WATERPROOF TAPE 1/2" X 10YD
MDR report key: 3641790
·
Received February 11, 2014
Report
- Report Number
- 1282497-2014-00013
- Event Type
- Other
- Date Received
- February 11, 2014
- Date of Event
- January 10, 2014
- Report Date
- January 21, 2014
- Manufacturer
- SCAPA GROUP PLC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH WATERPROOF TAPE. THE CUSTOMER REPORTS THAT THE TAPE LIFTED RESULTING IN THE ET TUBE DISLODGING AND THE PATIENT HAD TO BE EXTUBATED AND RE-INTUBATED. THE CUSTOMER STATES ALTERNATE METHODS WERE USED TO SECURE TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89565 | WATERPROOF TAPE 1/2" X 10YD | WATERPROOF TAPE | KGX | SCAPA GROUP PLC | 3063C | 202698X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |