FDA Adverse Event
Summary report: N
ANCHOR FAST
MDR report key: 2913424
·
Received November 2, 2012
Report
- Report Number
- 2913424
- Date Received
- November 2, 2012
- Date of Event
- September 3, 2012
- Report Date
- November 2, 2012
- Manufacturer
- HOLLISTER
- Product Code
- CBH
- Report Source
- User Facility report
- Reporter Location
- CT, US
Narratives
Description of Event or Problem · 1
ANCHOR FAST STRAP CAME APART WHILE ATTEMPTING TO SECURE ENDOTRACHEAL (ET) TUBE. THIS HAS HAPPENED 3 DIFFERENT TIMES WHILE ATTEMPTING TO SECURE ET TUBE. IT SEEMS THAT THE COMPANY REDESIGNED THE VELCRO STRAP AND MADE IT NARROWER BECAUSE OF SKIN ISSUES WITH THE ORIGINAL WIDE VERSION. HOWEVER, IN THIS DESIGN, THE GLUE HOLDING THE VELCRO PIECE TO THE CLOTH FAILED. THERE DOESN'T APPEAR TO BE ENOUGH SURFACE AREA FOR THE GLUE TO REALLY ADHERE TO THE CLOTH. WE BELIEVE THE COMPANY IS GOING BACK TO THE OLD DESIGN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANCHOR FAST | ET TUBE FASTENER | CBH | HOLLISTER | 9799 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |