FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2071933
·
Received April 20, 2011
Report
- Report Number
- 9610617-2011-00017
- Event Type
- Other
- Date Received
- April 20, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 18, 2011
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY, AT THE CONCLUSION OF A DIRECT LARYNGOSCOPY BRONCHOSCOPY AND DILATION OF SUB GLOTTIS STENOSIS PROCEDURE THAT LASTED 40 MINS, THE DOCTOR REMOVED LARYNGOSCOPE AND NOTED THAT THERE WAS A 1 CM BURN ON PT'S LOWER LIP. PLASTIC SURGEON CALLED IN FOR CONSULT AND CATEGORIZED IT AS A 1ST DEGREE BURN THAT COULD BE ADDRESSED WITH ANTIBIOTIC CREAM. CREAM WAS APPLIED AND PT RELEASED THE SAME DAY. PT CONDITION GOOD. PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | LARYNGOSCOPE | CCW | KARL STORZ GMBH & CO. KG | 8576E | MA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO | Other |