FDA Adverse Event
Injury
Summary report: N
ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER
MDR report key: 5004139
·
Received August 14, 2015
Report
- Report Number
- 1119193-2015-00010
- Event Type
- Injury
- Date Received
- August 14, 2015
- Report Date
- August 14, 2015
- Manufacturer
- HOLLISTER INCORPORATED
- Product Code
- CBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DESPITE NUMEROUS ATTEMPTS, NO DETAILED INFORMATION REGARDING THE PATIENT OR THE INCIDENT WAS ABLE TO BE OBTAINED FROM THE REPORTING HOSPITAL. THE GUARD PORTION OF THE DEVICE IS TO PREVENT THE ET TUBE FROM BEING SEVERED OR OCCLUDED AND APPEARS TO HAVE FUNCTIONED AS INTENDED. PATIENT SEDATION MAY HAVE BEEN INADEQUATE TO PREVENT SUCH FORCEFUL BITING BY THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BIT DOWN ON THE TUBE PROTECTION SLEEVE (GUARD) OF THE ANCHORFAST GUARD ENDOTRACHEAL TUBE FASTENER AND BROKE TWO FRONT TEETH. DESPITE NUMEROUS ATTEMPTS, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538734 | ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER | ANCHORFAST ETAD | CBH | HOLLISTER INCORPORATED | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |