FDA Adverse Event
Injury
Summary report: N
ACHOR FAST
MDR report key: 3874224
·
Received June 11, 2014
Report
- Report Number
- MW5036602
- Event Type
- Injury
- Date Received
- June 11, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 10, 2014
- Manufacturer
- HOLLISTER
- Product Code
- CBH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT HAD A BREAKDOWN IN HIS MOUTH REGION THAT APPEARS TO BE RELATED TO THE ENDOTRACHEAL TUBE SECURING DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343862 | ACHOR FAST | ETT HOLDER | CBH | HOLLISTER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |