FDA Adverse Event
Malfunction
Summary report: N
THE DENVER SPLINT
MDR report key: 698120
·
Received March 29, 2006
Report
- Report Number
- 698120
- Event Type
- Malfunction
- Date Received
- March 29, 2006
- Date of Event
- March 15, 2006
- Report Date
- March 29, 2006
- Manufacturer
- SHIPPERT MEDICAL TECHNOLOGIES CORPORATION
- Product Code
- EPP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGEON APPLIED DENVER SPLINT AFTER NASAL SURGERY. IT WAS NOTED THAT SMALL AMOUNTS OF THE PAINT FLAKED OFF FROM THE SPLINT ONTO THE PATIENT'S EYE AREA. SURGEON IMMEDIATELY REMOVED ALL OF THE FLAKES USING A SUCTION AND THERE WAS NO INJURY TO THE PATIENT AND THE SURGEON DID NOT WANT THE SPLINT REMOVED. ON 3/23/06, A SURGERY STAFF MEMBER NOTIFIED MANUFACTURER AND MANUFACTURER INDICATED AWARENESS OF FLAKING PROBLEM, HOWEVER THEY BELIEVED IT WAS RESOLVED. MANUFACTURER WILL REPLACE OUR CURRENT STOCK OF SMALL/MEDIUM SPLINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE DENVER SPLINT | SPLINT, NASAL | EPP | SHIPPERT MEDICAL TECHNOLOGIES CORPORATION | SERIES 1500 KIT SMALL/MEDIUM | 10030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |