FDA Adverse Event
Other
Summary report: N
HOLLISTER ETAD
MDR report key: 479881
·
Received August 21, 2003
Report
- Report Number
- 1119193-2003-00005
- Event Type
- Other
- Date Received
- August 21, 2003
- Report Date
- August 19, 2003
- Manufacturer
- HOLLISTER INCORPORATED
- Product Code
- CBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A WOUND DEVELOPED BETWEEN THE UPPER LIP AND NOSE WHILE WEARING THE ETAD. IT WAS FURTHER REPORTED THAT PLASTIC SURGERY WILL BE REQUIRED TO REPAIR THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOLLISTER ETAD | ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE | CBH | HOLLISTER INCORPORATED | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |